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 2015-10-30 for CHROMID(TM)] CPS? ELITE TRANSLUCENT 418284 manufactured by Biomerieux Sa.
[29998199]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[29998200]
On (b)(6), 2015 a customer called to report when using chromid cps elite, (b)(4), lot 1004212710, the specimen colony at 18-24 hr. Incubation is red typical e. Coli (ifu states spontaneous red to burgundy coloration) and after 48h incubation, the colony became blue-green. Customer tested strain further using ast method and results did not confirm e. Coli. Testing at 48 hours with vitek 2 gn card, strain was identification as enterobacter cloacae dissolvans. Customer stated there was a delay in reporting patient results.
Patient Sequence No: 1, Text Type: D, B5
[35050884]
Biom? Rieux internal investigation was conducted. The submitted strain was identified as enterobacter cloacae complex with an excellent interval of confidence detection. As defined in the package insert, chromid tm cps elite 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. According to the vitek? 2 report, this strain identified as enterobacter cloacae express ss-gal; this explains why the beginning color development is pink and later becomes green. The strain is not escherichia coli as indicated by the customer; it is an enterobacter cloacae growing as escherichia coli (at 24 hours) due to its enzymatic activity. The chromid tm cps elite agar product limitations indicate certain species may produce colonies of the same characteristic color as e. Coli (ex. : citrobacter). In this particular case, this behavior is related with the enzymatic profile of the bacteria. As it express ss-gal, the strain is able to develop the typical color observed in e. Coli. The chromid tm cps elite agar is working in accordance with specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00133 |
| MDR Report Key | 5192381 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-10-30 |
| Date of Report | 2015-10-27 |
| Date Mfgr Received | 2015-10-27 |
| Device Manufacturer Date | 2015-08-07 |
| Date Added to Maude | 2015-10-30 |
| 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 TRANSLUCENT |
| Generic Name | CHROMID(TM)] CPS? ELITE TRANSLUCENT |
| Product Code | JXA |
| Date Received | 2015-10-30 |
| Catalog Number | 418284 |
| Device Expiration Date | 2015-12-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-10-30 |