MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 1997-02-21 for MATRIX HCV REAGENT 4A46-26 manufactured by Abbott Laboratories.
[7830679]
Initial report stated that a redraw sample was matrix hcv indeterminant (section b. 5 paragraph 2). This sample was actually positive (core=positive, ns4 (yeast)=positive and ns4 (coli) positive. Product was expired, no sample was available. No evaluation was performed as the device was not returned and the pt sample was not available. A file kit from this lot was evaluated and met performance expectations. Product labeling states: 1) matrix hcv is an immunodot assay which can be used to obtain additional info on hcv immunoassay reactive specimens and diagnostic specimens. 2) a test result that is negative does not exclude the possiblity of exposure to or infection with hcv. Negative results in this assay in individuals with prior exposure to hcv may be due to antibody levels below the limit of detection with this assay. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
[19235540]
A pt identified by the facility as drug addicted, was tested for hepatitis c virus with the hcv assay on 9/28/96 and 10/1/96. The results were negative. The facility also performed the hcv for a positive result. Pcr testing was positive and the riva 3. 0 was positive for ns3 and ns4. The pt was reported as "positive" for hcv. The facility received a field correction notice that was distributed on 12/5/96 that included the lot of reagent used to test this pt's sample. The discrepant result was observed, and the pt was redrawn. The pt was wia positive, riba 3. 0 positive (ns3, ns4, and core), and matrix hcv determinant (ns3, ns4=0. 5, core = positive). The facility is a refernce center. The negative results obtained on the hcv was not reported. Positive results were obtained and reported by the other assays. The pt's diagnosis was not effected by the discrepancy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-1997-00002 |
| MDR Report Key | 71619 |
| Report Source | 00,01,05 |
| Date Received | 1997-02-21 |
| Date of Report | 1997-02-20 |
| Date of Event | 1996-10-01 |
| Date Mfgr Received | 1997-01-21 |
| Device Manufacturer Date | 1996-08-01 |
| Date Added to Maude | 1997-02-28 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NONE |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MATRIX HCV REAGENT |
| Generic Name | EIA FOR DETECTION OF HCV ANTIGEN |
| Product Code | LQI |
| Date Received | 1997-02-21 |
| Model Number | NA |
| Catalog Number | 4A46-26 |
| Lot Number | 20711M100 |
| ID Number | NA |
| Device Expiration Date | 1996-11-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 71506 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD ABBOT PARK IL 600643500 US |
| Baseline Brand Name | MATRIX HCV REAGENT |
| Baseline Generic Name | EIA FOR DETECTION OF HCV ANTIGEN |
| Baseline Model No | NA |
| Baseline Catalog No | 4A46-26 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-02-21 |