MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-09-24 for ABBOTT HCV EIA 2.0 4A14-24 manufactured by Abbott Laboratories.
[153218]
On 7/24/98 the account reported a nonrective result for the hepatitis c virus 2. 0 eia assay, lot 40002m400, on a pt sample which later tested positive with hepatitis c virus "riba" assay. The "riba" assay reported the following bands present: 5-1-1, c100-3, c22-3. A second sample from the pt was tested 8/3/98 with lot 42227m100 and nonreactive results were reported. Repeat testing was performed with the second sample and nonreactive results were obtained agin with the hepatitis c virus 2. 0 eia assay. The first sample wa not available for repeat testing. Positive results were obtained for the second sample with the "riba" assay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-1998-00006 |
| MDR Report Key | 197499 |
| Report Source | 06 |
| Date Received | 1998-09-24 |
| Date of Report | 1998-09-23 |
| Date of Event | 1998-07-24 |
| Date Mfgr Received | 1998-08-24 |
| Device Manufacturer Date | 1998-05-01 |
| Date Added to Maude | 1998-11-19 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 1998-09-24 |
| Model Number | NA |
| Catalog Number | 4A14-24 |
| Lot Number | 40002M400 |
| ID Number | NA |
| Device Expiration Date | 1999-01-06 |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 191877 |
| 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 | 0 | 1998-09-24 |