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 2016-03-17 for CHROMID? CPS? ELITE AGAR 416172 manufactured by Biom?rieux Sa.
[40594487]
A customer in (b)(6) reported finding turquois colonies in the amount of 10,000, while using the; chromid cps elite. The colonies did not show an real convex colony growth, they are however; growing into the agar. So, the customer is not able to do an agar diffusion-test. Also, the customer is not able to perform a gram stain and no further id. There was a delay in results as the customer incubated the plate for 24 hours more in order to see if the colonies in the agar grew larger. The customer ordered a urine sample from the patient. For one patient sample, such colonies could be observed, the customer checked the urine after one week and identified klebsiella without the colonies. An investigation will be initiated by biomerieux.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2016-00056 |
| MDR Report Key | 5507915 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-17 |
| Date of Report | 2018-03-28 |
| Date Mfgr Received | 2016-05-20 |
| Date Added to Maude | 2016-03-17 |
| 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. 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 | 5, RUE DES AQUEDUCS |
| Manufacturer City | CRAPONNE, FR 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 | 2016-03-17 |
| Catalog Number | 416172 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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, FR 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-17 |