MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-28 for TDXFLX SYSTEM 04A24-96 manufactured by Abbott Manufacturing Inc.
[71051444]
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
[71051445]
The customer observed visible smoke while using the tdx analyzer. The customer reported visible smoke from right hand side of instrument and the display/keypad was hot to the touch. No visible flame or sparks were observed. The customer has turned system off and unplugged it. There was no injuries reported and no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[73131589]
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. The tdxflx system operations manual contains information on operational precautions and limitations, and directions for emergency shutdown of the tdx/flx analyzer. The tdx/tdxflx service manual addresses the removal and replacement of the reagent display door with board. The reagent display door with board (part number 3-45036-01) was replaced. Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2017-00082 |
| MDR Report Key | 6439874 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-28 |
| Date of Report | 2017-04-04 |
| Date of Event | 2017-03-11 |
| Date Mfgr Received | 2017-04-04 |
| Device Manufacturer Date | 1993-02-17 |
| Date Added to Maude | 2017-03-28 |
| 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 | 2017-03-28 |
| 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 | 2017-03-28 |