MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-05-23 for BV BLUE, GRYPHUS DIAGNOSTICS manufactured by .
[18489743]
Bacterial vaginosis test kit failure resulting in false positive results. In 2008, bv results reviewed, noted significant increase in positive tests starting approximately about 2 weeks before. Micro quality control records indicated that a new lot number #b2042- bv kit had been opened about 3 days prior. Issue reported to mfr and kits returned. Dates of use: 2008. Diagnosis or reason for use: bacterial vaginosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5007024 |
| MDR Report Key | 1052145 |
| Date Received | 2008-05-23 |
| Date of Report | 2008-05-23 |
| Date of Event | 2008-04-27 |
| Date Added to Maude | 2008-06-03 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | BV BLUE, GRYPHUS DIAGNOSTICS |
| Generic Name | NONE |
| Product Code | MXB |
| Date Received | 2008-05-23 |
| Returned To Mfg | 2008-05-15 |
| Lot Number | B2042 |
| Device Expiration Date | 2008-11-30 |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1022248 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-05-23 |