MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-09 for PANBIO WEST NILE VIRUS IGM CAPTURE ELISA manufactured by Inverness Medical Innovations Australia Pty Ltd 532.
[920597]
Statement of problem: about 80% of the pt specimens collected in the month of 2008 that were reported by viromed as positive for west nile igm antibody using the panbio west nile virus igm capture elisa, failed to confirm by a center panel of serologic test results including igm capture elisa, microsphere immunoassay to west nile envelope and ns5, and immunofluorescence assay to encephalitis virus. The probable source of error is the mfr's selection of assay cutoff calibrator. Viromed has confirmed independently an assay false positive rate of about 80%. Viromed is a national resource to physicians for west nile virus serology. Pt care providers, and public health agencies should consider as suspect positive reports for west nile virus igm antibody where the panbio west nile virus igm capture elisa was used for specimen analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008254 |
| MDR Report Key | 1156004 |
| Date Received | 2008-09-09 |
| Date of Report | 2008-09-09 |
| Date Added to Maude | 2008-09-18 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PANBIO WEST NILE VIRUS IGM CAPTURE ELISA |
| Generic Name | PANBIO WEST NILE VIRUS IGM CAPTURE ELISA |
| Product Code | LRM |
| Date Received | 2008-09-09 |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1183119 |
| Manufacturer | INVERNESS MEDICAL INNOVATIONS AUSTRALIA PTY LTD 532 |
| Manufacturer Address | SEVENTEEN MILE ROCKS RD. SINNAMON PARK QUEENSLAND AS 4073 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-09 |