MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-02-22 for ABBOTT HCV EIA 2.0 4A14-31 manufactured by Abbott Laboratories.
[18334372]
A known hcv positive pt tested negative on abbott hcv eia 2. 0 but had previously tested positive on another eia method (unk) and pcr. The sample was sent to another lab and tested positive on an ortho eci 3rd generation anti-hcv method but was negative on riba.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2006-00002 |
| MDR Report Key | 684176 |
| Report Source | 06 |
| Date Received | 2006-02-22 |
| Date of Report | 2006-01-26 |
| Date of Event | 2006-01-12 |
| Date Mfgr Received | 2006-01-26 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2006-03-10 |
| 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 BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| 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 | 2006-02-22 |
| Model Number | NA |
| Catalog Number | 4A14-31 |
| Lot Number | 32481M100 |
| ID Number | NA |
| Device Expiration Date | 2006-02-01 |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 673422 |
| 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 | 2006-02-22 |