MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-07-27 for ABBOTT HCV EIA 2.0 4A14-64 manufactured by Abbott Laboratories.
[531496]
The customer stated two samples obtained from a pt tested non-reactive on hcv eia 2. 0, but were reactive on axsym anti-hcv. The samples were sent to a reference lab for riba testing and were reactive for two proteins (c33c and c22b). The customer stated the riba results correlate with the axsym results and believes the pt is seroconverting. 1
Patient Sequence No: 1, Text Type: D, B5
[7799277]
The pt sample has been requested, but it has not yet been received. The sample will be evaluated for anti-hcv status using file inventory of hcv eia 2. 0 reagents. Based upon in-house test results of the sample, appropriate reference testing will be performed to properly classify the anti-hcv status of this sample. Further performance evaluation of the hcv eia 2. 0 reagents will not be performed as the lot number involved is unk. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2006-00017 |
| MDR Report Key | 751182 |
| Report Source | 06 |
| Date Received | 2006-07-27 |
| Date of Report | 2006-06-30 |
| Date of Event | 2006-05-20 |
| Date Mfgr Received | 2006-06-30 |
| Date Added to Maude | 2006-08-18 |
| 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 | 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 | 2006-07-27 |
| Model Number | NA |
| Catalog Number | 4A14-64 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 738993 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 AND 200 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-27 |