MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-06-28 for ABBOTT HCV EIA 2.0 4A14-31 manufactured by Abbott Laboratories.
[508354]
The account generated discrepant hcv eia 2. 0 and axsym anti-hcv results during a correlation study. On april 13, 2005, the specimen tested hcv eia 2. 0 initially nonreactive (0. 727 s/co, cutoff=0. 428) and repeated nonreactive (0. 248, 0. 263 s/co, cutoff=0. 483). The specimen also tested axsym anti-hcv initially reactive (15. 78 s/co) was centrifuged again and repeated axsym anti-hcv reactive (14. 98, 13. 33 s/co). The patient tested negative for hav-igm, hbsag and anti-hbc-igm. The account does not know whether the hcv eia 2. 0 or the axsym anti-hcv result is correct. Then, the specimen was sent to abbott laboratories for investigation which generated riba 3. 0 indeterminate (c33c 4+) results. No additional testing information is available. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[7794209]
Investigation is in process, no results or conclusions can be made.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2005-00022 |
| MDR Report Key | 744133 |
| Report Source | 06 |
| Date Received | 2005-06-28 |
| Date of Report | 2005-06-28 |
| Date of Event | 2005-04-13 |
| Date Mfgr Received | 2005-06-13 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2006-08-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID SPINDELL, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479351869 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2005-06-28 |
| Model Number | NA |
| Catalog Number | 4A14-31 |
| Lot Number | 22201M200 |
| ID Number | NA |
| Device Expiration Date | 2005-07-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 731930 |
| 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 | 4A14-31 |
| 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 | 2005-06-28 |