MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-11-30 for ABBOTT HCV EIA 2.0 4A14-23 manufactured by Abbott Laboratories.
[142593]
On or around 10/28/98, the account received a false negative result for the hepatitis c virus 2. 0 gen. Assay compare to hepatitis c virus polymarase chain and two other serological tests on a donor sample. Ribo-nucleic acid hepatitis c virus: positive; hepatitis c virus 2. 0: "d. O" = 0. 275, 0. 221, cutoff = 0. 451.
Patient Sequence No: 1, Text Type: D, B5
[6078940]
On or around 10/28/98, the account recieved a false negative result for the hepatitis c virus 2. 0 gen. Assay compare to hepatitis c virus polymarase chain reaction and two other serological tests on a donor sample. Ribo-nucleic acid hepatitis c virus: positive; hepatitis c virus 2. 0: "d. O" = 0. 275, 0. 221, cutoff = 0. 451. See section b6 for other serological test results.
Patient Sequence No: 2, Text Type: D, B5
[6316536]
On or around 10/28/98, the account received a false negative result for the hepatitis c virus 2. 0 gen. Assay compare to hepatitis c virus polymarase chain reaction and two other serological tests on a donor sample. Ribo-nucleic acid hepatitis c virus: positive; hepatitis c virus 2. 0: "d. O" = 0. 275, 0. 221, cutoff = 0. 451. See section b6 for other serological test results.
Patient Sequence No: 3, Text Type: D, B5
| Report Number | 1415939-1998-00010 |
| MDR Report Key | 200523 |
| Report Source | 06 |
| Date Received | 1998-11-30 |
| Date of Report | 1998-11-25 |
| Date of Event | 1998-10-28 |
| Date Mfgr Received | 1998-10-28 |
| Device Manufacturer Date | 1998-04-01 |
| Date Added to Maude | 1998-12-08 |
| 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 | 1998-11-30 |
| Model Number | NA |
| Catalog Number | 4A14-23 |
| Lot Number | 40347M100 |
| ID Number | NA |
| Device Expiration Date | 1999-01-06 |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 194777 |
| 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 | 4A14-23 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-11-30 | |
| 2 | 0 | 1998-11-30 | |
| 3 | 0 | 1998-11-30 |