MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-25 for CHROMID? CANDIDA AGAR 43631 manufactured by Biom?rieux Sa.
[73619460]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[73619461]
A customer in (b)(6) reported the occurrence of false negative (no growth) for yeast from a vaginal specimen. Testing via alternate agar media (cpse, pvx, anc) obtained good growth. Identification testing (vitek? 2 yst id test kit) produced a result of "no identification. " blastese test was positive; customer concluded candida albicans. Incubation time allowed by the customer = 48 hours. Instructions for use (ifu) indicate incubation up to 72 hours. Plates were stored at 4? C in a lighted environment. This practice is outside the ifu; the plates should be stored in a manner protected from light. Additionally, the ifu indicates "growth depends on the requirements of each individual microorganism. It is therefore possible that certain yeast strains which have specific requirements (substrate, temperature, etc. ) may not grow or may not produce color. " the customer stated no incorrect result was reported to the treating physician, and there was no adverse impact to the patient's state of health. Biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00078 |
| MDR Report Key | 6518599 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-25 |
| Date of Report | 2017-08-14 |
| Date Mfgr Received | 2017-07-19 |
| Device Manufacturer Date | 2017-01-30 |
| Date Added to Maude | 2017-04-25 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 | 3 |
| Brand Name | CHROMID? CANDIDA AGAR |
| Generic Name | CHROMID? CANDIDA AGAR |
| Product Code | JSI |
| Date Received | 2017-04-25 |
| Catalog Number | 43631 |
| Lot Number | 1005462060 |
| Device Expiration Date | 2017-05-08 |
| 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 | 2017-04-25 |