MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-02-18 for TDXFLX SYSTEM 04A24-02 manufactured by Abbott Manufacturing Inc.
[16864418]
The customer stated that a tdx/flx analyzer that had been stored unused for quite some time was put into operation and smoke was observed coming from the back of the analyzer when it was powered on. The cause of the smoke was determined to be a burnt analog circuit board. No fire was observed. The customer replaced the circuit board, but the analyzer was not operational. There was no injury to the user or damage to the laboratory due to the smoke.
Patient Sequence No: 1, Text Type: D, B5
[17078672]
The serial number on the tdx/flx analyzer was unreadable. The analyzer was intended to be used in a research laboratory and would not be used for testing patient samples. It is unknown how the customer obtained the analyzer. The customer stated that the tdx/flx will not be repaired and will not be used. A product labeling review determined that the tdx/flx system operations manual and the tdx/tdxflx analyzer service manual contain adequate information for the described issue. A historical quality data review did not identify any adverse trend for burning/smoking analog board #1 issues. The current complaint was found to be the only occurrence of this issue. 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. Available information does not reasonably suggest a malfunction caused this issue. The history of the tdx/flx and the condition of the analyzer at the time of the occurrence are not known as the serial number is not available. No deficiency was identified. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2015-00084 |
| MDR Report Key | 4524309 |
| Report Source | 01,05 |
| Date Received | 2015-02-18 |
| Date of Report | 2015-01-28 |
| Date of Event | 2015-01-28 |
| Date Mfgr Received | 2015-01-28 |
| Date Added to Maude | 2015-03-23 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2015-02-18 |
| Catalog Number | 04A24-02 |
| 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 | 2015-02-18 |