MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-05-09 for FACTOR VIII ANTIBODY SCREEN F8S manufactured by Immucor Gti Diagnostics, Inc..
[4543554]
A customer complaint was received (cmp-216) which described that the factor viii antibody screen (f8s) assay results were negative (neg) and the laboratory's in-house (b)(6) assay results were positive. The ordering physician was expecting (b)(6) results ( units - bu) and contacted lab when they did not receive the bu results. The laboratories testing paradigm was to test samples on the f8s kit and if positive results (pos) were obtained, then the sample was refluxed to the (b)(6) assay. The initial customer notification was provided to manufacturer on (b)(6 )2014. After multiple requests of customer, samples were sent on (b)(6) 2014 to manufacturer. Internal testing showed that the concerned lot of product was performing as expected when using internal well-characterized samples. The (b)(6) assay is in internal lab developed test. The laboratory has changed their testing paradigm due to this information to reflux samples to the (b)(6) assay if f8s is less than 20 percent activity.
Patient Sequence No: 1, Text Type: D, B5
[12139004]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183608-2014-00001 |
| MDR Report Key | 3902584 |
| Report Source | 05,06 |
| Date Received | 2014-05-09 |
| Date of Report | 2014-05-06 |
| Date of Event | 2014-04-14 |
| Date Mfgr Received | 2014-02-28 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-07-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| Manufacturer Phone | 2627541009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FACTOR VIII ANTIBODY SCREEN |
| Generic Name | FACTOR VIII ANTIBODY SCREEN |
| Product Code | GGP |
| Date Received | 2014-05-09 |
| Model Number | NA |
| Catalog Number | F8S |
| Lot Number | 3001285 |
| ID Number | NA |
| Device Expiration Date | 2015-07-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Address | WAUKESHA WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-09 |