MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-07-06 for ABBOTT HCV EIA 2.0 4A14-31 manufactured by Abbott Laboratories.
[16787717]
Account was performing lookback testing on donors who had previously reactive hcv screening results. This donor was redrawn and was tested with abbott hcv 2. 0 eia and was non-reactive. Riba 2. 0 testing was indeterminate (c100 = 1+, c33 = 2+, sod = 2+). No report of injury.
Patient Sequence No: 1, Text Type: D, B5
[16882422]
Account was performing lookback testing on donors who had previously reactive hcv screening results. This donor was redrawn and was tested with abbott hcv 2. 0 eia and was non-reactive. Riba 2. 0 testing was reactive (5-1-1 = 1+, c100 = 1+, c33 = 2+). No report of injury.
Patient Sequence No: 2, Text Type: D, B5
[16884130]
Account was performing lookback testing on donors who had previously reactive hcv screening results. This donor was redrawn and was tested with abbott hcv 2. 0 eia and was non-reactive. Riba 2. 0 testing was reactive (c100 = 1+, c33 = 2+, c22 = 2+). No report of injury.
Patient Sequence No: 3, Text Type: D, B5
| Report Number | 1415939-1998-00004 |
| MDR Report Key | 176460 |
| Report Source | 05,06 |
| Date Received | 1998-07-06 |
| Date of Report | 1998-07-02 |
| Date of Event | 1998-05-19 |
| Date Mfgr Received | 1998-06-02 |
| Device Manufacturer Date | 1998-04-01 |
| Date Added to Maude | 1998-07-14 |
| 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 | 1998-07-06 |
| Model Number | NA |
| Catalog Number | 4A14-31 |
| Lot Number | 39413M400 |
| ID Number | NA |
| Device Expiration Date | 1998-10-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 171555 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. 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 | 4A14-31 |
| 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 | 0 | 1998-07-06 | |
| 2 | 0 | 1998-07-06 | |
| 3 | 0 | 1998-07-06 |