MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-04 for TDXFLX SYSTEM 04A24-96 manufactured by Abbott Manufacturing Inc.
[30617431]
Further investigation of the customer issue included instrument maintenance, a review of the complaint text, a search for similar complaints and a review of labeling. The fse replaced the reagent display door with board (part number (b)(4)), which was worn out from normal use and verified the system to be functional again after replacement. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. Based on all available information and abbott diagnostics' complaint investigation, no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[30617432]
The customer observed visible smoke coming from the tdx analyzer. The field service engineer (fse) identified the source of the smoke as coming from the electronic area of the door. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2015-00273 |
| MDR Report Key | 5201146 |
| Date Received | 2015-11-04 |
| Date of Report | 2015-11-04 |
| Date Mfgr Received | 2015-10-13 |
| Device Manufacturer Date | 1992-03-10 |
| Date Added to Maude | 2015-11-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 0 |
| Brand Name | TDXFLX SYSTEM |
| Generic Name | AUTOMATED FLUORESCENT IMMUNOASSAY ANALYZER |
| Product Code | JJQ |
| Date Received | 2015-11-04 |
| Catalog Number | 04A24-96 |
| 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 | 2015-11-04 |