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 2018-09-17 for CHROMID? CARBA AGAR 43861 manufactured by Biomerieux S.a..
[120736743]
A customer in (b)(6) reported false resistant results in association with chromid? Carba agar (lot 1006576530). The customer performed cre (carbapenemase-resistant enterobacteriaceae) screening on the chromid agar and green colonies were grown. There were two size colonies (large and medium) and both were tested using vitek? 2 ast and etest?. [1] colony size : large (isolate 1, specimen 2144); vitek2 gn id : klebsiella pneeumoniae ssp pneumoniae; vitek2ast-n224 : ertapenem 4 r / imipenem 0. 5* r*; e-test : ertapenem 0. 5 s / imipenem 0. 38 s. [2] colony size : medium (isolate 3, specimen 2144); vitek2 isolate number (b)(4); vitek2gn id : klebsiella pneeumoniae ssp pneumoniae; vitek2ast-n224 : ertapenem 2 r / imipenem 0. 25* r*; e-test : ertapenem 0. 5 s / imipenem 0. 5 s. No patient information was provided by the customer. 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. Later, the customer reported they lost isolates 1 and 3 of specimen 2144, and provided other strains for investigation. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00185 |
| MDR Report Key | 7882374 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-17 |
| Date of Report | 2019-02-06 |
| Date Mfgr Received | 2019-01-10 |
| Device Manufacturer Date | 2018-06-15 |
| Date Added to Maude | 2018-09-17 |
| 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 AGAR |
| Generic Name | CHROMID? CARBA AGAR |
| Product Code | JSO |
| Date Received | 2018-09-17 |
| Catalog Number | 43861 |
| Lot Number | 1006576530 |
| Device Expiration Date | 2018-08-30 |
| 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 | 2018-09-17 |