MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-06-05 for CHROMID CANDIDA 43631 manufactured by Biom?rieux Sa.
[22720492]
The customer reported lack of growth when testing a patient sample in conjunction with chromid candida agar (ref. 43631 - lot 1003875550 expiry 29-jun-2015) whereas microscopic examination of the concerned specimens revealed the presence of candida. The customer stated the same patient sample was inoculated via alternate method (rice agar) and growth of candida species, mostly c. Albicans, was observed following incubation. The customer stated that no false negative results were reported to a physician. The customer has not claimed any injury, death, unnecessary medical procedure or negative impact to the patient due to the chromid agar behavior. Patient isolate submittal has been requested. An internal biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[39544107]
The customer did not submit isolate strains for internal testing. The internal investigation was conducted using chromid candida retained samples of the same lot as that used by the customer (ref. (b)(4), lot 1003850260), and using the same strains as used during product release testing. All results were in accordance with specifications: good growth in 48 hours of candida albicans with characteristic blue colonies (atcc 2091 and atcc 10231). Good growth in 48 hours of candida tropicalis and candida kefyr with characteristic pink colonies (atcc 9968 and atcc 1162). Inhibited growth of other strains. Review of the associated manufacturing batch record confirmed no documented anomaly to explain the customer report of no growth of candida strain. The batch sterilization time and the results of the microbiological quality control were accordance with specifications. The issue reported by the customer could not be duplicated. The investigation concluded that the performance of chromid candida ref (b)(4), lot 1003850260 is within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00039 |
| MDR Report Key | 4821536 |
| Report Source | 01,05,06 |
| Date Received | 2015-06-05 |
| Date of Report | 2015-05-12 |
| Date of Event | 2015-04-30 |
| Date Mfgr Received | 2015-05-12 |
| Date Added to Maude | 2015-07-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID CANDIDA |
| Generic Name | CHROMID CANDIDA AGAR |
| Product Code | JSI |
| Date Received | 2015-06-05 |
| Catalog Number | 43631 |
| Lot Number | 1003850260 |
| Device Expiration Date | 2015-06-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-06-05 |