MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-28 for CHROMID? CANDIDA AGAR 43631 manufactured by Biom?rieux Sa.
[113009982]
A customer in (b)(6) contacted biom? Rieux to report a false negative result for a vaginal sample in association with chromid? Candida agar. The customer stated the agar grew pink colonies, characteristic of candida tropicalis, candida lusitaniae and candida kefyr. Confirmatory testing via vitek ms obtained organism identification to candida albicans. For candida albicans, the chromid candida growth should have been pale blue to dark blue. Therefore, the sample was misidentified at the species level. There was no indication or report from the laboratory or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00089 |
| MDR Report Key | 7647428 |
| Date Received | 2018-06-28 |
| Date of Report | 2018-08-17 |
| Date Mfgr Received | 2018-07-31 |
| Device Manufacturer Date | 2018-04-17 |
| Date Added to Maude | 2018-06-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CHROMID? CANDIDA AGAR |
| Generic Name | CHROMID? CANDIDA AGAR |
| Product Code | JSJ |
| Date Received | 2018-06-28 |
| Catalog Number | 43631 |
| Lot Number | 1006444850 |
| Device Expiration Date | 2018-07-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-28 |