MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-10-04 for ABBOTT HCV EIA 2.0 4A14-24 manufactured by Abbott Laboratories.
[17821747]
The account generated an initially negative hcv eia 2. 0 result. After reviewing the run data, the account noticed the absorbance values were depressed on the controls. The entire run was repeated with freshly made conjugate. The sample tested reactive with the freshly made conjugate. The sample was tested again in duplicate with repeatedly reactive results. According to the account's quality control absorbance results, the initial run should have been rejected, but all run absorbances were within abbott's acceptable parameters. No additional testing was performed on sample. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2001-00002 |
| MDR Report Key | 355470 |
| Report Source | 06 |
| Date Received | 2001-10-04 |
| Date of Report | 2001-10-03 |
| Date of Event | 2001-08-31 |
| Date Mfgr Received | 2001-09-04 |
| Device Manufacturer Date | 2001-04-01 |
| Date Added to Maude | 2001-10-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAUL LANDESMAN, D-09D5, AP6C-6 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643500 |
| Manufacturer Phone | 8479372688 |
| 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 | 2001-10-04 |
| Model Number | NA |
| Catalog Number | 4A14-24 |
| Lot Number | 76552M101 |
| ID Number | NA |
| Device Expiration Date | 2001-11-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 344689 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD 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 | 2001-10-04 |