MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-14 for TDXFLX SYSTEM 04A24-96 manufactured by Abbott Manufacturing Inc.
[18890923]
The customer observed smoke coming from the right side panel of the tdxflx analyzer. The customer indicated they were attempting to run a calibration at the time. They unplugged the analyzer upon seeing the smoke. There was no injury to the instrument operator or impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[19229033]
(b)(4). An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[36870206]
Further evaluation of the customer issue included a review of the complaint text, review of the analyzer by abbott field service, review of service history, a search for similar complaints, and a review of labeling. A photo of the reagent display board was provided and reviewed. The abbott field service engineer (fse) identified a burnt component on the reagent display board and replaced the board. Review of the service history, for instrument serial number (b)(4), did not identify any other issues that may have contributed to the current complaint issue. A tracking and trending review was completed; no adverse trend for smoking for the reagent display board was identified. Labeling was reviewed and it was determined that adequate instructions, as to the specific requirements for safe and optimum performance of the system, are provided. Based on the available information no product deficiency of the tdxflx, list number 04a24, was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2015-00157 |
| MDR Report Key | 4771638 |
| Report Source | 05 |
| Date Received | 2015-05-14 |
| Date of Report | 2015-04-20 |
| Date of Event | 2015-04-20 |
| Date Mfgr Received | 2015-05-21 |
| Device Manufacturer Date | 1993-10-25 |
| Date Added to Maude | 2015-05-21 |
| 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 | 2015-05-14 |
| 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 | 2015-05-14 |