MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-03-04 for ABBOTT HCV EIA 4A14-24 manufactured by Abbott Laboratories.
[91814]
The patient was redrawn and tested on feb. 14, 1997 with the hcv eia 2. 0 assay for a non-reactive result.
Patient Sequence No: 1, Text Type: D, B5
[7768662]
Return samples, obtained from the same patient on different draws, 1/20/97 and 2/2/97, were non-reactive with the hcv eia 2. 0. Upon further testing by our inhouse lab, one of the return samples was interpreted to be anti-hcv positive on the supplemental immunodot assay, the other sample was negative when tested with the immunodot assay. It can be concluded that the negative antibody result obtained with the hcv eia 2. 0 may be due to antibody levels below the limit of detection of this assay or lack of antibody reactivity to the hcv antigens used in the assay. The patient was redrawn on 2/14/97 and the sample was found to be repeat reactive when tested by abbott on the hcv eia 2. 0 assay and anti-hcv positive on the immunodot supplemental testing. Samples found positive by hcv supplemental testing are considered positive for antibodies to hcv. The patient appears to be exhibiting a typical seroconversion immune response based on the results of the testing of the 2/14/97 redraw. Further testing with seroconversion panels was performed and verified that sensitivity claims were met. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-1997-00005 |
| MDR Report Key | 74863 |
| Report Source | 05,06 |
| Date Received | 1997-03-04 |
| Date of Report | 1997-03-04 |
| Date of Event | 1997-01-20 |
| Date Mfgr Received | 1997-02-05 |
| Date Added to Maude | 1997-03-11 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT HCV EIA |
| Generic Name | EIA FOR DETECTION OF HCV ANTIBODY |
| Product Code | LQI |
| Date Received | 1997-03-04 |
| Model Number | NA |
| Catalog Number | 4A14-24 |
| Lot Number | 22409M200 & 24789M100 |
| ID Number | NA |
| Device Expiration Date | 1997-05-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 74659 |
| 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 | 1. Other | 1997-03-04 |