MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2007-09-12 for ABBOTT HCV EIA 2.0 4A14-64 manufactured by Abbott Laboratories.
[683077]
A sample tested in 1994 using commander hepatitis c assay was negative. During a look back on pts, the status of a pt changed from negative to positive using prism hcv assay. The pt was an anti-d recipient of an infected product in 1994.
Patient Sequence No: 1, Text Type: D, B5
[7851295]
Investigation is currently in process. This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2007-00219 |
| MDR Report Key | 911037 |
| Report Source | 01,05 |
| Date Received | 2007-09-12 |
| Date of Report | 2007-08-21 |
| Date of Event | 1994-01-01 |
| Date Mfgr Received | 2007-08-21 |
| Date Added to Maude | 2007-09-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID BARCH, D-09Y6, AP6C-02 |
| Manufacturer Street | 100 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| 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 | 2007-09-12 |
| Model Number | NA |
| Catalog Number | 4A14-64 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 886211 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-09-12 |