MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-27 for OXOID DR680M * manufactured by Oxoid Ltd., C/o Lifesign.
[312228]
The lab received a new test kit for the performance of serum infectious mononucleosis ("mono"). During regular lab testing, several pt specimens were tested with the kit, all testing as negative. Both negative and positive control specimens furnished with the kit worked correctly. However, two positive specimens from an external survey failed to react (were false negative). Several pt specimens had been tested with the kit and were all negative. Therefore, doctors were informed of possible erroneous results and pts were rechecked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033510 |
| MDR Report Key | 552485 |
| Date Received | 2004-08-27 |
| Date of Report | 2004-08-24 |
| Date of Event | 2004-07-01 |
| Date Added to Maude | 2004-11-02 |
| 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 | 3 |
| 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 | OXOID |
| Generic Name | INFECTIOUS MONONUCLEOSIS TEST KIT |
| Product Code | KTN |
| Date Received | 2004-08-27 |
| Model Number | DR680M |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 542033 |
| Manufacturer | OXOID LTD., C/O LIFESIGN |
| Manufacturer Address | P.O. BOX 218 SUMERSET NJ 088750218 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-08-27 |