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 2016-04-19 for CHROMID? CPS ELITE AGAR PLATES 416172 manufactured by Biom?rieux Sa.
[43018701]
A customer in (b)(6) notified biomerieux of a discrepant false negative result associated with chromid cps elite agar plates (reference (b)(4)the customer reported the media shrinking and results with no growth. Incubation was confirmed at 37 deg c for 24 hours. The customer indicated patient results were not affected. In addition, the customer indicated there was no evidence to support erroneous results were reported to a physician, patients were treated incorrectly or harmed, and/or delays in reporting results.
Patient Sequence No: 1, Text Type: D, B5
[46504921]
A customer in (b)(6) notified biom? Rieux of a discrepant false negative result associated with chromid? Cps elite agar plates (reference (b)(4)). The customer reported the media shrinking and results with no growth. An internal biom? Rieux investigation was performed with results as follows: no other complaints linked to batch 1004658500. Problem determined to not be related to customer error/incorrect incubation. Product identified as being more sensitive to shrinkage than other culture media. Chromid? Cps elite shrinkage issue associated with capa (b)(4). Internal corrective actions implemented as a result of the investigation conclusions: position chromid? Cps elite agar plates from lid down to lid up position to unify the way customers. Are receiving plates and help decrease retraction issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00068 |
| MDR Report Key | 5587237 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-19 |
| Date of Report | 2016-04-15 |
| Date Mfgr Received | 2016-04-15 |
| Date Added to Maude | 2016-04-19 |
| 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 | BIOM |
| Manufacturer Street | 5, RUE DES AQUEDUCS |
| Manufacturer City | CRAPONNE, FR 69290 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69290 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? CPS ELITE AGAR PLATES |
| Generic Name | CHROMID? CPS ELITE AGAR PLATES |
| Product Code | JXA |
| Date Received | 2016-04-19 |
| Catalog Number | 416172 |
| Lot Number | 1004658500 |
| Device Expiration Date | 2016-06-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-04-19 |