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? VRE ID AGAR 20 PLT 43004 manufactured by Biomerieux S.a..
[120737126]
A customer in (b)(6) reported false positive results when using chromid? Vre id agar 20 plt (lot 1006583800). The customer performed tests with rectal samples from three (3) patients, and growth of typical purple colonies of enterococcus faecium vancomycin b were obtained. The identification of the strains was confirmed as enterococcus faecium with mass spectrometry. The customer stated that qc results were conforming. The customer tested the strains on the vitek? 2 ast-p606 card and the results were vancomycin susceptible the customer sent the strains to another laboratory (cnr) and the results were negative with pcr and microdilution. The customer stated that the results were reported to the clinician and the patients were isolated unnecessarily. The patients did not have antibiotic treatment. 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 patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00182 |
| MDR Report Key | 7882142 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-17 |
| Date of Report | 2018-11-13 |
| Date Mfgr Received | 2018-10-19 |
| Device Manufacturer Date | 2018-06-19 |
| 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? VRE ID AGAR 20 PLT |
| Generic Name | CHROMID? VRE ID AGAR 20 PLT |
| Product Code | JSO |
| Date Received | 2018-09-17 |
| Catalog Number | 43004 |
| Lot Number | 1006583800 |
| Device Expiration Date | 2018-09-15 |
| 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 |