MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-04-13 for TDXFLX SYSTEM 04A24-01 manufactured by Abbott Manufacturing Inc.
[5636985]
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 Sequence No: 1, Text Type: D, B5
[13144991]
(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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2015-00133 |
| MDR Report Key | 4686408 |
| Report Source | 01,05 |
| Date Received | 2015-04-13 |
| Date of Report | 2015-03-19 |
| Date Mfgr Received | 2015-03-19 |
| Device Manufacturer Date | 1992-03-12 |
| Date Added to Maude | 2015-05-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TDXFLX SYSTEM |
| Generic Name | AUTOMATED FLUORESCENT IMMUNOASSAY ANALYZER |
| Product Code | JJQ |
| Date Received | 2015-04-13 |
| Catalog Number | 04A24-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-13 |