MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-11-05 for ABBOTT HCV EIA 2.0 4A14-24 manufactured by Abbott Laboratories.
[143017]
On 10/2/98, a tray jam occurred on the "ppc" and two false negative results for hcv 2. 0 eia were obtained from the run. All units were reprocessed and none of the donor units from the tray jam were transfused. However, the units of blood were released to the donor pool afer completion of testing on 10/2/98. Reprocessing results were reported to abbott customer svc ctr on 10/8/98. According to the account, hcv and destination maps stamped with incubation times in and out of the dynamic incubator were listed. The "ppc" tray jam was indicated on both incubation logs. The power had to be cycled to remove the jammed tray. The tray jam occurred on the first incubation, delaying the time in the dynamic incubator for the second incubation. The tray exceeded the incubation time for the frist incubation error code info is not available because the tray tickets were disregarded by the account. No further info has been provided by the account. Varying results were received for a donor sample being".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-1998-00008 |
| MDR Report Key | 196559 |
| Report Source | 06 |
| Date Received | 1998-11-05 |
| Date of Report | 1998-11-04 |
| Date of Event | 1998-10-02 |
| Date Mfgr Received | 1998-10-08 |
| Device Manufacturer Date | 1998-08-01 |
| Date Added to Maude | 1998-11-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT HCV EIA 2.0 |
| Generic Name | EIA FOR DETECTION OF HCV ANTIBODY |
| Product Code | LQI |
| Date Received | 1998-11-05 |
| Model Number | NA |
| Catalog Number | 4A14-24 |
| Lot Number | 44741M100 |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 190964 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US |
| Baseline Brand Name | ABBOTT HCV EIA 2.0 |
| Baseline Generic Name | EIA FOR DETECTION OF HCV ANTIBODY |
| Baseline Model No | NA |
| Baseline Catalog No | 4A14-24 |
| Baseline ID | NA |
| Baseline Device Family | ABBOTT HCV EIA 2.0 |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 40392 | 1998-11-05 |