MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-20 for TDXFLX SYSTEM 04A24-96 manufactured by Abbott Manufacturing Inc.
[43447172]
(b)(4). Hazy smoke with a burning odor was observed from an infrequently used tdxflx during assay calibration with the access door open. A review of service history for the tdxflx, serial number (b)(4), did not identify any issues that may have contributed to the current complaint. A review for similar complaints against the tdxflx analyzer found no similar issues or trends identified. A review of the tdx/flx system operations manual gives adequate instructions for shut down of the analyzer and also advises keeping all access doors closed to prevent damage to the air heater and the photomultiplier tube while running. The ambassador configured the system 2 parameters to disallow assay runs with the access door open. Additionally, a review of the 2016 ul certification memo contains adequate information noting abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment. Based on this investigation no systemic deficiency or malfunction was identified for the tdxflx (list number 04a24-96), serial number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[43447173]
The customer observed smoke coming from the sample carousel area on the tdxflx analyzer. The customer stated that the smoke dissipated quickly and a burning odor was present. The customer stated that the analyzer is not used frequently. No flames were observed and no injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[74380452]
The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended, and conclusions code was corrected from (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2016-00101 |
| MDR Report Key | 5588462 |
| Date Received | 2016-04-20 |
| Date of Report | 2017-04-21 |
| Date of Event | 2016-03-30 |
| Date Mfgr Received | 2017-04-17 |
| Device Manufacturer Date | 1994-09-28 |
| Date Added to Maude | 2016-04-20 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 2016-04-20 |
| Catalog Number | 04A24-96 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2016-04-20 |