MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-07-31 for ETEST? VANCOMYCIN VA 256 WW S30 525518 manufactured by Biomerieux Sa.
[115927385]
On (b)(6) 2018, a eucast member reported to biom? Rieux a potential publication related to the underestimation of mic value for enterococci with a low level of resistance, in association with etest? Vancomycin va 256 ww s30 (ref. (b)(4)). The eucast development laboratory confirmed the findings from a (b)(6) reference laboratory for resistant enterococci strains (mic value >4 mg/l) with a van b genotype regarding an underestimation of the mics value with etest? Vancomycin va 256 (ref. (b)(4)) that led for some of the isolates to a susceptible result on etest? Instead of resistant. The study compared etest? Vancomycin to the broth micro dilution reference method and the results were: essential agreement: 63%, category agreement: 38%, false susceptible: 63%. No patient outcomes were reported due to the referenced issue. There is no indication or report that the discrepant results led to any adverse event related to any patient's state of health. A biom? Rieux internal investigation has been initiated and impacted strains were requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00123 |
| MDR Report Key | 7735896 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-07-31 |
| Date of Report | 2018-11-29 |
| Date Mfgr Received | 2018-10-30 |
| Device Manufacturer Date | 2017-10-04 |
| Date Added to Maude | 2018-07-31 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318805 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD |
| Manufacturer City | LA BALME LES GROTTES ISERE 383, |
| Manufacturer Country | FR |
| 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 | 2018-07-31 |
| Catalog Number | 525518 |
| Lot Number | 1006011340 |
| Device Expiration Date | 2018-10-04 |
| 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 SA |
| Manufacturer Address | 3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE 383, FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-31 |