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 2018-09-06 for CHROMID? CARBA SMART 414685 manufactured by Biomerieux S.a..
[120264304]
A customer in (b)(6) reported there was no growth of a proteus mirabilis strain on chromid? Carba smart agar (lot 1006566660). The customer reported that the patient had a positive cytobacterioligical urine exam, and was identified as a carrier of proteus mirabilis carba ndm-1. A rectal swab was tested on the chromid carba smart agar, and the customer stated they observed citrobacter growth, but the proteus carba ndm-1 did not grow. The strain had good growth on esbl (extended spectrum beta-lactamase) media. The customer tested the proteus strain from urine on the carba smart, and there was no growth. The customer stated that potentially an incorrect result was reported to a physician, and there was no patient impact or delay. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00177 |
| MDR Report Key | 7850410 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-06 |
| Date of Report | 2018-12-26 |
| Date Mfgr Received | 2018-11-28 |
| Device Manufacturer Date | 2018-06-11 |
| Date Added to Maude | 2018-09-06 |
| 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. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX S.A. |
| Manufacturer Street | 5 RUE DES AQUEDUCS |
| Manufacturer City | CRAPONNE, 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? CARBA SMART |
| Generic Name | CHROMID? CARBA SMART |
| Product Code | JSO |
| Date Received | 2018-09-06 |
| Catalog Number | 414685 |
| Lot Number | 1006566660 |
| Device Expiration Date | 2018-08-26 |
| 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 | 2018-09-06 |