MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-20 for FACTOR VIII ANTIBODY SCREEN F8S manufactured by Immucor Gti Diagnostics, Inc..
[114713193]
Customer complaint (b)(4) was received on (b)(6) 2017 for factor viii antibody screen (303283) lot 3004682. The customer reported that a (b)(6) year old male patient had factor viii antibody screen assay results that were negative, and the laboratory's bethesda assay results were positive (2. 4 titer). Factor vii antibody screen assay results are also dependent on the progression of antibody formation as well as if/when fviii therapy is administered. The patient's course of therapy was not available from the laboratory.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00002 |
| MDR Report Key | 7706639 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-20 |
| Date of Report | 2017-11-27 |
| Date of Event | 2017-11-27 |
| Date Mfgr Received | 2017-11-27 |
| Device Manufacturer Date | 2016-12-14 |
| Date Added to Maude | 2018-07-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ERIKA HEWITT |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| Manufacturer Phone | 2627541006 |
| Manufacturer G1 | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53186 |
| 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 | 2018-07-20 |
| Catalog Number | F8S |
| Lot Number | 3004682 |
| Device Expiration Date | 2018-09-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Address | 20925 CROSSROADS CIRCLE WAUKESHA WI 53186 US 53186 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-20 |