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.
[43479279]
(b)(4). A follow-up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[43479280]
The customer stated that they observed smoke coming from the right side of the tdx/tdxflx instrument behind the display panel when they were running a calibration. There was no visible damage or fire seen. The customer powered the unit off and unplugged. There was no reported injury or impact to user safety and no impact to analytical patient results.
Patient Sequence No: 1, Text Type: D, B5
[44183898]
Smoke was observed coming from tdxflx, serial number (b)(4), during assay calibration. The customer powered off and unplugged the analyzer. The field service engineer (fse) identified several damaged resistors on the reagent display door with board (part number 3-45036-01) and replaced the part. The fse verified the system to be functional again after replacement of the reagent display door with board. A return was not available but the fse provided two file images that confirm the damage on the part. A review of the service history did not identify any issues that may have contributed to the current complaint. The tdx/flx system operations manual contains adequate information on operational precautions and limitations of the analyzer. A review of the 2016 ul certification memo found 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. A review of history for the reagent display door with board (part number 3-45036-01) found no trends. Based on this investigation no systemic deficiency or malfunction was identified for the reagent display door with board (part number 3-45036-01).
Patient Sequence No: 1, Text Type: N, H10
[74629134]
The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2016-00103 |
| MDR Report Key | 5588460 |
| Date Received | 2016-04-20 |
| Date of Report | 2017-04-26 |
| Date of Event | 2016-03-25 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 1992-07-01 |
| 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 |