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 2017-12-11 for CHROMID? CPS? ELITE AGAR 416172 manufactured by Biom?rieux Sa.
[95747222]
A customer in (b)(6) reported the occurrence of post-use mold contamination in association with the chromid? Cps elite (cpse) agar, lot 1005920130. The customer stated the media was stored in the original box at 4-8? C as indicated in package insert and instructions for use and opened just before use. Customer indicated they always use cpse plates in combination with cos plates for urinary tract infection. After incubation, the customer found mold contamination on some of the cpse plates. The customer stated they incubated one cpse plate directly out of the original box and found it also contaminated. The customer stated the final identification was provided based on the cos plate result. Therefore the cpse result was not reported to the physician, and no patient result was directly impacted by the issue. Biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00399 |
| MDR Report Key | 7104658 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-11 |
| Date of Report | 2018-01-16 |
| Date Mfgr Received | 2017-12-19 |
| Device Manufacturer Date | 2017-08-24 |
| Date Added to Maude | 2017-12-11 |
| 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 | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 5 RUE DES AQUEDUCS |
| Manufacturer City | CRAPONNE, 69290 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69290 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? CPS? ELITE AGAR |
| Generic Name | CHROMID? CPS? ELITE AGAR |
| Product Code | JXA |
| Date Received | 2017-12-11 |
| Catalog Number | 416172 |
| Lot Number | 1005920130 |
| Device Expiration Date | 2017-12-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 5 RUE DES AQUEDUCS CRAPONNE, 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-11 |