Investigating Medical Devices Customer Complaints

[Weeder]

FDA QSR and ISO 13485 require handling of customer complaints. The regulation states that manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. It is not clear what investigation really means?

We find that every complaints that comes in has to be investigated to some extent. Think of it as a 2-stage investigation.

In the first stage, we investigate why the customer experienced a problem and whether it was due to a defect in the product or or a problem on the customer side, or perhaps a user error. If the problem is on the customer side, no further investigation is necessary and the complaint is closed

However, if the problem is with our product, than an investigation into what happened and how to fix the problem is necessary. This is formally documented.

My question is, is this the correct way of handling customer complaints? Can anyone clarify wht the regulation mean by investigation?

 

[somashekar]

Re: Investigating customer complaints

In the first stage, we investigate why the customer experienced a problem and whether it was due to a defect in the product or or a problem on the customer side, or perhaps a user error. If the problem is on the customer side, no further investigation is necessary and the complaint is closed

This is review and evaluate

However, if the problem is with our product, than an investigation into what happened and how to fix the problem is necessary. This is formally documented.

This is investigation

 

[blobnda]

Re: Investigating customer complaints

I woud add that it is important to track and trend these user error complaints because they may point to potential issues with your user instructions or training. A series of this type of customer error may necessitate a CAPA from your company.

 

[Sidney Vianna]

Re: Investigating customer complaints

FDA QSR and ISO 13485 require handling of customer complaints. The regulation states that manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. It is not clear what investigation really means?

We find that every complaints that comes in has to be investigated to some extent. Think of it as a 2-stage investigation.

In the first stage, we investigate why the customer experienced a problem and whether it was due to a defect in the product or or a problem on the customer side, or perhaps a user error. If the problem is on the customer side, no further investigation is necessary and the complaint is closed

However, if the problem is with our product, than an investigation into what happened and how to fix the problem is necessary. This is formally documented.

My question is, is this the correct way of handling customer complaints? Can anyone clarify wht the regulation mean by investigation?

Firstly, you need to pay close attention to the (ISO 13485) definition of complaint. It is much broader than what many people understand. Don't dismiss customer feedback, simply because your organization feels the problem is due to misuse.

Secondly, I believe the FDA is pretty clear about the investigation process, especially the bit about the records:

Investigation Records
The designated unit or person(s) responsible for maintaining the complaint file(s) shall prepare a written record of any investigations. This record shall include [820.198(e)]:
(1) The name of the device;

(2) The date the complaint was received;

(3) Any device identification(s) and control number(s) used;

(4) The name, address, and phone number of the complainant;

(5) The nature and details of the complaint;

(6) The dates and results of the investigation;

(7) Any corrective action taken; and

(8) Any reply to the complainant.
Also, the investigation record of any complaint that is being reported to FDA in an MDR report shall include a determination of [820.198(e)]:
(1) Whether the device failed to meet specifications;

(2) Whether the device was being used for treatment or diagnosis; and

(3) The relationship, if any, of the device to the reported incident or adverse event.
Section 820.198(e) requires the record of investigation to include any reply to the complainant. Manufacturers should send a reply to each complainant as a courtesy, but more important to prevent further misuse, injury or other adverse situations from recurring. However, because of the nature of the complaint, there may be cases where a reply is not necessary. In such cases, the record should state that no reply was made and the reason for not replying. When the problem was caused by misuse, it is very important to advise the user to help prevent further misuse. Also, the manufacturer should determine if inadequate labeling may have lead to misuse.

If you want, you can use ISO 10002 as a guidance document to structure a robust customer complaint system.

 

[Weeder]

Re: Investigating customer complaints

Thanks Somashekar,

That was very helpful and has cleared up the confusion I had.

 

[Doug Tropf]

The FDA's Small Entity Compliance Guide has an excellent section on handling complaints.