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 418229 manufactured by Biom?rieux Sa.
[43015990]
A customer in (b)(6) notified biomerieux of discrepant results associated with chromid cps elite agar. The customer reported the plates contained no substrate. The seeding robot, wasp, did not catch this and the samples were delayed. One set was discovered before the plates were incubated and therefore, nothing happened. The second set was discovered after incubation and resulted in a delay of one (1) day. The customer indicated not having information related to the patients.
Patient Sequence No: 1, Text Type: D, B5
[45374445]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with chromid? Cps elite agar. The customer reported the plates contained no substrate. An internal biom? Rieux investigation was conducted. Results included: first complaint for this batch received between manufacturing date and expiration. The customer reported four (4) plates affected by this problem from a total of (b)(4) plates released ((b)(4) of batch affected; not considered a systemic issue at batch level). First complaint involving lack of media related to the manufacturing site; not considered a systemic issue related to this problem. A total of (b)(4) plates were inspected by quality control (qc) according to sampling plan; 100% of the plates conformed according to visual aspect, which included plate volume. Batch record review indicated in-process control was performed every 15 minutes; regarding the volume, all controls conformed. Non-conformities and/or observations that could explain the problem were not found. The results of the internal investigation did not confirm the reported complaint. No additional actions have been scheduled by the manufacturing site at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00067 |
| MDR Report Key | 5587225 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-19 |
| Date of Report | 2016-03-30 |
| Date Mfgr Received | 2016-03-30 |
| 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 |
| Generic Name | CHROMID?CPS ELITE AGAR |
| Product Code | JXA |
| Date Received | 2016-04-19 |
| Catalog Number | 418229 |
| Lot Number | 1004597090 |
| Device Expiration Date | 2016-03-30 |
| 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 |