MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 1997-03-21 for ABBOTT HCV EIA 4A14-32 manufactured by Abbott Gmbh Diagnostika.
[49397]
In aug. Of 1996 a donor tested non-reactive for hepatitis c virus. The unit was released for transfusion but the pt died in surgery. The donor is a regular and returned to donate a unit in nov. That was transfused into a 16 yr old female. The weight of the recipient is unk. The nov. Unit also tested negative with the hcv eia assay. Later the 16 yr old recipient was diagnosed with hepatitis c virus. The recipient was pcr positive. The donor of the unit returned for testing. The donor was tested on hcv 2nd generation assay for a non-reactive result on 1/20/97. The donor sample on 1/20/97 had an elevated alanine aminotransferase result. The donor was non-reactive for hcv and was reactive for ns3 only on the matrix hcv assay. The donor was tested by the following assays not manufactured by co: a. Eia 3rd generation for a reactive result; b. Pastuer for a negative result per package insert but greyzone reactive for bloodbanking criteria; c. Riba was 3+ for ns3 only; d. Pcr was positive. Further pt or donor info is unk.
Patient Sequence No: 1, Text Type: D, B5
[22248868]
Code 100 - a potential false negative result was obtained with a sample drawn on nov. 14, 1996 using abbott hcv eia lot 21193hp00. This false negative result was confirmed in the investigation using a file kit from the same lot number. The sample identified from nov. 14, 1996 was pcr positive. Subsequent bleeds from jan. 24, 1997, feb. 3, 1997 and feb. 19, 1997 of the same lot number. None of the subsequent bleeds were tested by pcr in the investigation. The labeling for this assay states that a test result which is negative does not exclude the possibility of exposure to or infection with hcv. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-1997-00008 |
| MDR Report Key | 78651 |
| Report Source | 00,01,05,06 |
| Date Received | 1997-03-21 |
| Date of Report | 1997-03-20 |
| Date of Event | 1996-11-14 |
| Date Mfgr Received | 1997-02-18 |
| Device Manufacturer Date | 1996-09-01 |
| Date Added to Maude | 1997-03-27 |
| 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 | 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 | 1997-03-21 |
| Model Number | NA |
| Catalog Number | 4A14-32 |
| Lot Number | 21193HP00 |
| ID Number | NA |
| Device Expiration Date | 1997-03-21 |
| 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 | 78273 |
| Manufacturer | ABBOTT GMBH DIAGNOSTIKA |
| Manufacturer Address | MAX-PLANCK-RING 2 65205 WIESBADEN DELKENHEIM GM |
| Baseline Brand Name | ABBOTT HCV EIA 2.0 |
| Baseline Generic Name | EIA FOR DETECTION OF HCV ANTIBODY |
| Baseline Model No | NA |
| Baseline Catalog No | 4A14-32 |
| 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 | 1997-03-21 |