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 2018-08-23 for CHROMID? CARBA SMART 414685 manufactured by Biomerieux S.a..
[118559062]
A customer from (b)(6) reported there was no growth for two isolates from the same transplant patient, when using chromid? Carba smart agar (lot 1006515680). The isolates were tested on the vitek? 2 ast-n246 card: m64053-1 urine e. Coli; m64965-1 rectal screening swab k. Pneumoniae; m64965-2 rectal screening swab e. Coli ; both the urine and rectal swabs were resistant for meropenem. The isolates were confirmed as imp4 positive by pcr. The customer did not provide information on the results that were reported or patient impact. 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 | 3002769706-2018-00160 |
| MDR Report Key | 7810966 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-23 |
| Date of Report | 2018-11-19 |
| Date Mfgr Received | 2018-10-24 |
| Device Manufacturer Date | 2018-05-21 |
| Date Added to Maude | 2018-08-23 |
| 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 | MRS. DEBRA BROYLES |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318805 |
| 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 | 2018-08-23 |
| Catalog Number | 414685 |
| Lot Number | 1006515680 |
| Device Expiration Date | 2018-08-05 |
| 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 | 2018-08-23 |