MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-11-12 for ABBOTT HCV EIA 2.0 4A14-24 manufactured by Abbott Laboratories.
[17833277]
The account generated a nonreactive hcv 2. 0 eia result (patient s/co = 0. 178, cuttoff = 0. 389) on a known positivie patient specimen. The specimen repeated hcv 2. 0 eia nonreactive using a different reagent lot. The specimen tested viral load positive of 870,000 (no units of measurement given). In addition, the account tested the specimen using dilutions with nonreactive hcv 2. 0 eia results (1:4 = 0. 206, 1:8 =0. 215, 1:16= 0. 260, 1:32=0. 214). The patient has a history of testing hcv positive. No additional patient information is available. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2003-00031 |
| MDR Report Key | 496506 |
| Report Source | 06 |
| Date Received | 2003-11-12 |
| Date of Report | 2003-11-12 |
| Date of Event | 2003-09-23 |
| Date Mfgr Received | 2003-10-17 |
| Date Added to Maude | 2003-11-21 |
| 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 RD |
| 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 ANTIGEN |
| Product Code | LQI |
| Date Received | 2003-11-12 |
| Model Number | NA |
| Catalog Number | 4A14-24 |
| Lot Number | 07189M100 |
| ID Number | 06292M200 |
| Device Expiration Date | 2004-02-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 485242 |
| 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 | 4A14-24 |
| 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 | 2003-11-12 |