MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-07 for EBV IGM KIT EB150-E manufactured by Gull Laboratories, Inc..
[16279325]
Serologic testing using epstein-barr virus igm kit has yielded apparent false positive results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009661 |
| MDR Report Key | 35044 |
| Date Received | 1996-08-07 |
| Date of Report | 1996-08-05 |
| Date of Event | 1996-06-01 |
| Date Added to Maude | 1996-08-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EBV IGM KIT |
| Generic Name | DIAGNOSTIC REAGENT FOR EPSTEIN-BARR |
| Product Code | JRY |
| Date Received | 1996-08-07 |
| Catalog Number | EB150-E |
| Lot Number | 6CLBXR |
| Device Expiration Date | 1997-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 36461 |
| Manufacturer | GULL LABORATORIES, INC. |
| Manufacturer Address | 1011 E 4800 SOUTH SALT LAKE CITY UT 84117 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-08-07 |