MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-21 for CHROMID CPS ELITE TRANSLUCENT 100 PLT 416172 manufactured by Biomerieux Sa.
[26613691]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[26613692]
A customer called in complaining of a contaminate on (b)(4),chromid(tm) chromid cps plates, lot 1004145580 discovered after incubation. Bacterium contamination is presenting as a brownish-yellow unidentified colony. Customer reports no patient results were affected. An internal investigation has been launched using retained plates.
Patient Sequence No: 1, Text Type: D, B5
[37853606]
Review of qc batch records indicate conformance to specifications. During the investigation, sixty (60) chromid tm cps elite agar plates were tested; the plates were associated with three (3) different timeframes of the manufacturing process for the identified batch (11:25, 16:24 and 19:40). The plates were not inoculated. The plates were incubated for five (5) days at 33-37? C. Results conformed to specifications for contamination; zero (0) contaminations observed in 60 plates. There is no evidence of a contamination issue with the chromid tm cps elite agar product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00096 |
| MDR Report Key | 5091648 |
| Date Received | 2015-09-21 |
| Date of Report | 2015-08-27 |
| Date Mfgr Received | 2015-08-27 |
| Device Manufacturer Date | 2015-07-09 |
| Date Added to Maude | 2015-09-21 |
| 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 CPS ELITE TRANSLUCENT 100 PLT |
| Generic Name | CHROMID CPS ELITE TRANSLUCENT 100 PLT |
| Product Code | JXA |
| Date Received | 2015-09-21 |
| Catalog Number | 416172 |
| Lot Number | 1004145580 |
| Device Expiration Date | 2015-11-04 |
| 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 | 2015-09-21 |