MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-10 for WEST NILE IGM EIA EL0300M manufactured by Focus Diafnostics.
[5101268]
Since (b)(6) 2013, laboratories began experiencing problems with the west nile igm eia, specifically that the kits would not pass, that the calibrators were out of range, high. The product is the west nile igm eia produced by (b)(6), product #el0300m. We have since learned that multiple laboratories were impacted, they too, being told that they were the only laboratory impacted. Some of the affected labs discontinued testing. There was no notification to the users of this product. I cannot say more because i was instructed not to contact you, but i believe the appearance of possible intentional deceit on the part of the mfr requires that i contact you, that i am ethically bound to notify you, even at this later date. The problem as far as we know was, and maybe still is, ongoing. Dates of use: 10/01/2013-10/10/2014. Diagnosis or reason for use: for treatment of west nile pts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038631 |
| MDR Report Key | 4182063 |
| Date Received | 2014-10-10 |
| Date of Report | 2014-10-10 |
| Date of Event | 2013-10-01 |
| Date Added to Maude | 2014-10-20 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WEST NILE IGM EIA |
| Generic Name | NONE |
| Product Code | NOP |
| Date Received | 2014-10-10 |
| Model Number | EL0300M |
| Lot Number | MULTIPLE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOCUS DIAFNOSTICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-10 |