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 2018-11-20 for ETEST? VANCOMYCIN VA 256 WW S30 412488 manufactured by Biomerieux, Sa.
[129350070]
A customer in (b)(6) reported a false susceptible result for an enterococcus faecium vanb positive strain in association with etest? Vancomycin va 256 ww s30. The customer stated they obtained discrepant results for vancomycin between etest and the vitek? 2 ast-p655 card. The etest initial and repeat results were vancomycin susceptible (mic=-2), and the ast-655 card was initially susceptible (mic=0. 5), but changed to resistant as the vana phenotype was detected. The strain was tested by pcr vanb twice and was positive, confirming a vanb positive phenotype. A vanb enterococcus faecium strain is expected to be vancomycin resistant. The customer did not report any patient information. 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 | 3002769706-2018-00244 |
| MDR Report Key | 8089293 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-20 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-11-20 |
| 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, SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD |
| Manufacturer City | LA BALME, LES GROTTES ISERE 38390 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETEST? VANCOMYCIN VA 256 WW S30 |
| Generic Name | ETEST? VANCOMYCIN VA 256 WW S30 |
| Product Code | JWY |
| Date Received | 2018-11-20 |
| Catalog Number | 412488 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, SA |
| Manufacturer Address | 3 ROUTE DE PORT MICHAUD LA BALME, LES GROTTES ISERE 38390 FR 38390 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-20 |