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 2016-05-02 for CHROMID CARBA SMART AGAR 414685 manufactured by Biom?rieux Sa.
[44167308]
A customer in (b)(6) notified biomerieux of a discrepant result associated with chromid carba smart agar (reference 414685). The plate was inoculated with a quality control sample of e. Coli indicated as not being atcc strain, but from a microbiologist's carbapenemase collection that was isolated in tunisia in 2012 and produces tem, ctx-m-14 and oxa-244 enzymes. The customer indicated the organism is subbed from frozen each time qc is set up. The customer reported the organism grew scant pink on the carba side and there was no growth on the oxa side whereas, there should have only been growth on the oxa side.
Patient Sequence No: 1, Text Type: D, B5
[46119113]
A customer in (b)(6) notified biom? Rieux of a discrepant result associated with chromid? Carba smart agar (reference 414685) involving a quality control sample of e. Coli where the organism grew scant pink on the carba side and there was no growth on the oxa side. An internal biom? Rieux investigation was performed with results as follows: complaint history review revealed no additional complaints involving the customer's lot. Biom? Rieux requested the strain from the customer; however, the customer's strain was not received. A retention sample of the customer's lot (1004671720) in parallel with two lots of chromid? Carba smart agar (1004737760/1004760850) and a lot of cos were tested. Testing strains included escherichia coli2 (ref (b)(4)), proteus rettgeri2 (ref (b)(4)), klebsiella pneumoniae2 (ref (b)(4)) nctc (b)(4), enterobacter cloacae (ref (b)(4)), klebsiella pneumoniae2 (ref (b)(4)), klebsiella pneumoniae2 (ref (b)(4)), and klebsiella pneumoniae2 (ref (b)(4)). Results- after incubation under aerobic conditions at 33-37? C for 18-24 hours, product performance was within specifications regarding fertility and color intensity. There were no differences between lots detected. All positive strains were recovered and no false negative reactions were detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00078 |
| MDR Report Key | 5623945 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-02 |
| Date of Report | 2016-04-15 |
| Date Mfgr Received | 2016-04-15 |
| Device Manufacturer Date | 2016-02-19 |
| Date Added to Maude | 2016-05-02 |
| 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, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID CARBA SMART AGAR |
| Generic Name | CHROMID CARBA SMART AGAR |
| Product Code | JSI |
| Date Received | 2016-05-02 |
| Catalog Number | 414685 |
| Lot Number | 1004671720 |
| Device Expiration Date | 2016-05-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-05-02 |