All information below are fictional, for the purpose of discussion on what is really the "Aware Date":
product failure was reported by the user facility (e.g. hospital) to the manufacturer on 3/1/05, the date of the event. No injuries or death resulted. Per established complaint handling process, a complaint was opened for this alleged failure on 3/1/05 to initiate investigations. Company service engineer was dispatched to the user facility immediately to interview the user(s) and to examine the device.
Initial investigations (e.g. telnet to the device location to check sequence of actions that took place leading to the alleged failure) revealed that the device has functioned as intended per design controls process, with all mitigations (e.g. primary, secondary safety features and so forth) in place per risk management documentation. Review of component and device history from various quality data sources (e.g. DHR of this device unit, NCR data from manufacturing and component repair facilities, trended complaint data from the year this device was first manufactured, service data on this device at this user facility, device manuals including installation and servicing documentation, etc) revealed that there were no same or similar allegations in the past and device was installed and serviced as per manuals. No abnormal service history on this device was observed.
Competent panel of cross functional members (e.g. engineering, customer support, manufacturing, manufacturing QA, clinical and technical support, compliance, etc) reviewed all initial investigation results with QARA (who is responsible for the collection and reporting of adverse events) on 3/25/05. All agreed that based on investigation results gathered thus far the device has functioned as intended and that there is no risk of substantial harm posed to the public health. Thus, it was determined that this is not a reportable event per 803. All deliberation discussions and supporting evidence reviewed were documented and on file with the complaint record. Note: Company service engineer ordered a replacement subassembly on 3/1/05 and swapped the subassembly on-site on 3/3/05. Subassembly removed from the user facility was in transit to be returned to the company's manufacturing location for examination and testing (e.g. by Engineering to attempt to reproduce the alleged failure).
Subassembly was received at the company's manufacturing location on 3/9/05. Subassembly was examined and tested at the system level on 3/10/05 with the sequence of actions (commands that the user facility was performing leading to the alleged product failure on 3/1/05) using another device unit (manufacturing equivalent) in-house. Alleged failure was reproducible. Rigorous analysis was initiated on the subassembly level and at the component levels to identify the root cause(s). A few components were identified as possible initial root causes.
To make the story shorter, eventually on 4/5/05 all further investigation results became available from both in-house and suppliers, confirming product failure at the subassembly level (caused by 1 component). Panel of cross-functional members reviewed and analyzed these new investigation results with QARA on 4/5/05. All agreed that based on the new information the device has malfunctioned and concluded that this would be a reportable event now. Action plans were finalized. MDR was filed and C&R was initiated on 4/6/05. Component was re-designed and released through ECO process on 4/9/05. All in-house forward production used the re-designed component. Any devices shipped prior (including the complainant site) were corrected via FCO process. Again, all deliberation discussions and supporting evidence reviewed were documented and on file with the complaint record.
Now, if you are the QARA in this fictional example
, what date would you use as the “aware date” to be compliance with MDR (i.e. page 31 of Medical Device Report for Manufacturer http://www.fda.gov/cdrh/manual/mdrman.pdf).
Why do you feel the date you pick is the correct “aware date”? Based on the “aware date” you pick, are MDR and C&R filed on-time?