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 2015-12-11 for CHROMID(TM) CPS?ELITE 416172 manufactured by Biomerieux Sa.
[33265980]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[33265981]
A customer in (b)(6) reported to biomerieux misdentification of bacteria when using product chromid(tm) cpslite translucent. A pink enterobacter clocae was present from a urine sample after incubation 18-24h 37? Initially it was noted as e. Coli however; indole testing was negative. The vitekidentification (id) returned a 97% id for e. Clocae. There was a delay reporting results however, there was no return of incorrect results and no patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
[35029413]
Biom? Rieux internal investigation was conducted. As defined in the package insert, chromid tm cps elite translucent agar is used for identification of the bacteria most commonly isolated in urinary tract infections:? E. Coli: spontaneous red to burgundy coloration of strains producing ss-glucuronidase (ss-gur) and/or ssgalactosidase (ss-gal). ? Enterococcus: spontaneous turquoise coloration of strains producing ss-glucosidase (ss-glu). ? Kesc: spontaneous blue to green coloration of strains producing ss-glucosidase (ss-glu). ? Proteeae: spontaneous diffuse brown coloration of strains producing deaminase. The vitek? 2 report for the submitted strain indicates this enterobacter expresses ss-gal and therefore, according to the instructions for use of the media, it is expected to have coloration observed by the customer. The enzymatic profile of this strain is not typical. The chromid tm cps elite translucent agar product limitations indicate certain species may produce colonies of the same characteristic color as e. Coli (ex. : citrobacter). The chromid tm cps elite agar is working in accordance with specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00165 |
| MDR Report Key | 5288980 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-12-11 |
| Date of Report | 2015-11-24 |
| Date Mfgr Received | 2015-11-24 |
| Device Manufacturer Date | 2015-09-28 |
| Date Added to Maude | 2015-12-11 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID(TM) CPS?ELITE |
| Generic Name | CHROMID(TM) CPS?ELITE |
| Product Code | JXA |
| Date Received | 2015-12-11 |
| Catalog Number | 416172 |
| Lot Number | 1004327280 |
| Device Expiration Date | 2016-01-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-11 |