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 2016-01-06 for CHROMID(TM) CPS? ELITE AGAR 418284 manufactured by Biomerieux Sa.
[35215711]
A customer in (b)(6) reported discrepant results when using chromid(tm) cps elite agar; presence of a pink colony on cpse from urinary sample. There was no patient harm reported, however; there was a delay in the results due to the complementary testing.
Patient Sequence No: 1, Text Type: D, B5
[38799314]
An investigation into a misidentification when using the chromid cps? Elite agar was performed by biomerieux. The organism in question had an enzymatic profile performed on it. The enzymatic profile revealed that this particular enterobacter organism expressed ss-galactosidase. Based on the design of the chromid cps? Elite agar any organism that produces ss-galactosidase will produce a red to burgundy coloration of the medium. This red to burgundy coloration is most typical of e. Coli organisms and an enterobacter organism does not typically produce ss-galactosidase. Based on the enzymatic profile of the organism, the product is performing as expected. The package insert states that certain species may produce colonies of the same characteristic color as e. Coli (ex. : citrobacter) as a product limitation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00002 |
| MDR Report Key | 5349020 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-01-06 |
| Date of Report | 2015-12-16 |
| Date Mfgr Received | 2015-12-16 |
| Device Manufacturer Date | 2015-10-26 |
| Date Added to Maude | 2016-01-06 |
| 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 | 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 AGAR |
| Generic Name | CHROMID(TM) CPS? ELITE AGAR |
| Product Code | JXA |
| Date Received | 2016-01-06 |
| Catalog Number | 418284 |
| Lot Number | 1004399230 |
| Device Expiration Date | 2016-02-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-01-06 |