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 2018-03-13 for CHROMID? C. DIFFICILE AGAR 43871 manufactured by Biomerieux Spain.
[102350199]
A customer in (b)(6) reported a result of no growth, for a clostridium difficile quality control (qc) strain (b)(4)), in association with chromid? C. Difficile agar. The customer stated they inoculated a new lot of chromid? C. Difficile agar (lot 1006170510) with the qc strain, and had observed no bacterial growth after incubation at 36? C (+/- 1? C) in anaerobic atmosphere (generated by anaerobic jars). The customer stated that they perform the qc test for each new lot, and that clinical samples were not inoculated on this lot. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00036 |
| MDR Report Key | 7334715 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-13 |
| Date of Report | 2018-05-18 |
| Date Mfgr Received | 2018-04-26 |
| Date Added to Maude | 2018-03-13 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer G1 | BIOMERIEUX SPAIN |
| Manufacturer Street | ISAAC NEWTON, 6 |
| Manufacturer City | TRES CANTOS, MADRID 28760 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 28760 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? C. DIFFICILE AGAR |
| Generic Name | CHROMID? C. DIFFICILE AGAR |
| Product Code | JSI |
| Date Received | 2018-03-13 |
| Catalog Number | 43871 |
| Lot Number | 1006170510 |
| Device Expiration Date | 2018-04-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SPAIN |
| Manufacturer Address | ISAAC NEWTON, 6 TRES CANTOS, MADRID 28760 SP 28760 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-13 |