| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TDXFLX SYSTEM | AUTOMATED FLUORESCENT IMMUNOASSAY ANALYZER | ABBOTT MANUFACTURING INC | JJQ | 04A24-01 | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-04-13 | 0 |
Patient 1
THE CUSTOMER REPORTED A BURNT SMELL ACCOMPANIED BY VISIBLE SMOKE COMING FROM THE ABBOTT TDXFLX ANALYZER. NO INJURIES WERE REPORTED NOR ANY DAMAGE TO THE SURROUNDING LABORATORY ENVIRONMENT. THE POWER TO THE ANALYZER WAS TERMINATED AND THE POWER CORD PULLED FROM THE WALL OUTLET. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient 1
(B)(4). THE CUSTOMER OBSERVED SMOKE FROM AROUND THE SPECIMEN CAROUSEL LOADING POSITION OF THE TDX/FLX ANALYZER. NO FIRE WAS OBSERVED AND NOTHING WAS SEEN TO HAVE BEEN BURNT. NO FURTHER ACTION WAS TAKEN TO REPAIR THE ANALYZER AS THE CUSTOMER HAS MOVED ALL TESTING TO THE ARCHITECT SYSTEM. AN ABBOTT FIELD SERVICE ENGINEER AT THE CUSTOMER SITE VERIFIED THE CUSTOMER ISSUE AND THAT THE ANALYZER WAS UNPLUGGED FROM THE POWER OUTLET. THE TDX/FLX ANALYZER HAS BEEN REMOVED FROM THE CUSTOMER SITE. A RETURN IS NOT REQUIRED FOR INVESTIGATION BASED ON COMPLAINT TRACKING AND TRENDING METRICS (ENCOMPASSING 45 MONTHS) WHICH FOUND NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE TDX/FLX SYSTEM OPERATIONS MANUAL PROVIDES INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. A REVIEW OF THE RESULTS OF THIS EVALUATION AND INFORMATION FROM THE CUSTOMER SITE REASONABLY SUGGESTS A MALFUNCTION OCCURRED, WHICH CAUSED THE CAROUSEL LOADING POSITION TO SMOKE. THE SPECIFIC SOURCE AND CAUSE OF THE SMOKE WERE NOT IDENTIFIED. A SYSTEMIC DEFICIENCY RELATING TO THIS ISSUE WAS NOT FOUND.