MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-01-14 for ABBOTT HCV EIA 2.0 4A14-24 manufactured by Abbott Laboratories.
[348064]
The account generated a nonreactive hcv 2. 0 eia result (pt = 0. 248 s/co, cutoff = 0. 286 s/co) on a pt who was a known hcv positive pt. The pt also tested johnson & johnson eci reactive (pt = 7. 94, cutoff = 1. 0 no units of measurement given) using a different sample. Then, the pt tested hcv 2. 0 eia borderline reactive (pt = 0. 445 s/co, cutoff = 0. 415 s/co), riba positive and amplification positive at a reference laboratory. The initial nonreactive hcv 2. 0 eia result was reported outside of the laboratory and questioned by the physician. No impact to pt management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2005-00003 |
| MDR Report Key | 569332 |
| Report Source | 06 |
| Date Received | 2005-01-14 |
| Date of Report | 2005-01-11 |
| Date of Event | 2004-11-30 |
| Date Mfgr Received | 2004-12-17 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2005-02-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 ANTIBODY |
| Product Code | LQI |
| Date Received | 2005-01-14 |
| Model Number | NA |
| Catalog Number | 4A14-24 |
| Lot Number | 18230M200 |
| ID Number | NA |
| Device Expiration Date | 2005-02-03 |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 559183 |
| 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 | 6258 | 2005-01-14 |