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 2018-09-28 for CHROMID? CARBA SMART 414685 manufactured by Biomerieux S.a..
[124861446]
A customer in (b)(6) notified biomerieux of no growth and delayed results associated with chromid? Carba smart (reference (b)(4)). The customer reported observing no growth on chromid for escherichia coli on the oxa 48 side and small growth on the carba side of the plate. The antibiogram of the strain was resistant and the customer sent it to a reference laboratory. At the reference laboratory e. Coli was confirmed with the presence of a carbapenamse oxa 48 and the presence of an extended-spectrum beta-lactamases (esbl). Patient treatment was not impacted by this discrepancy. Initial treatment of the patient occurred in (b)(6) with bactrim (r), which did not relieve the patient's complaints for one (1) week. The patient sought further treatment in (b)(6). The patient's condition required nitrofurantoin according to the antibiogram, which he received in (b)(6), but hospitalization was not required. The following results were reported to the physician: "sent to the reference lab due to suspected cpe. " after one (1) week the confirmation by the reference lab was reported to the doctor: "cpe" (carbapenem-producing enterobacteriaceae), carbapenemase type oxa-48. Results were delayed due to the discrepant results by two (2) to three (3) days. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00189 |
| MDR Report Key | 7918708 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-28 |
| Date of Report | 2018-12-17 |
| Date Mfgr Received | 2018-11-19 |
| Device Manufacturer Date | 2018-06-18 |
| Date Added to Maude | 2018-09-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer G1 | BIOMERIEUX S.A. |
| Manufacturer Street | 5 RUE DES AQUEDUCS 692290 CRAPONNE |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? CARBA SMART |
| Generic Name | CHROMID? CARBA SMART |
| Product Code | JSO |
| Date Received | 2018-09-28 |
| Catalog Number | 414685 |
| Lot Number | 1006583300 |
| Device Expiration Date | 2018-09-02 |
| 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 S.A. |
| Manufacturer Address | 5 RUE DES AQUEDUCS CRAPONNE, 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-28 |