MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-20 for TDXFLX SYSTEM 04A24-01 manufactured by Abbott Manufacturing Inc.
[60423585]
An abbott field service engineer (fse) arrived at the customer site to inspect the abbott tdx/flx analyzer. The fse found no evidence of any burning of the reagent display door or associated printed circuit board. The fse proceeded to replace the suspect hardware. Subsequent instrument operations were acceptable. A review of the service history of the analyzer did not identify any issues that may have contributed to the current customer issue. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. The tdxflx system operations manual contains information to address the current customer issue. Based on the available information from the customer site and from the results of this evaluation, there is evidence to reasonably suggest a product malfunction occurred. A product deficiency is not indicated.
Patient Sequence No: 1, Text Type: N, H10
[60423586]
The customer called to report that the display keypad of the abbott tdx/flx analyzer began to feel hot to the touch and then starting smoking. No visible flames were observed. The issue was confined to the analyzer. No injuries or damage to the surrounding lab environment were reported. The customer powered off and unplugged the analyzer from the electrical outlet. A service call was initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2016-00287 |
| MDR Report Key | 6115891 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-20 |
| Date of Report | 2016-11-20 |
| Date of Event | 2016-11-09 |
| Date Mfgr Received | 2016-11-09 |
| Device Manufacturer Date | 1991-06-06 |
| Date Added to Maude | 2016-11-20 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | 2016-11-20 |
| 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 | 2016-11-20 |