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 2017-07-28 for CHROMID? VRE ID AGAR 43004 manufactured by Biomerieux Sa.
[81569026]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with chromid? Vre id agar (reference (b)(4)). The customer reported that the media had a bad selectivity for susceptible vancomycin enterococci. The customer provided five (5) examples that resulted in false positive results. The samples were collected from the rectal region for vre screening. The plates were streaked directly from the collected rectal swab and incubated for 24 - 48 hours. Results were as follows: sample a: growth on vre agar after 48 h incubation, vitek 2 susceptible (mic 1) no etest result. Sample b: growth on vre agar after 48 h incubation, vitek 2 susceptible (mic 1) va-etest = 1,0? G/ml (s). Sample c: growth on vre agar after 24 h incubation, vitek 2 susceptible (mic 2) va-etest = 2,0? G/ml (s). Sample d: growth on vre agar after 24 h incubation, vitek 2 susceptible (mic 2) va-etest = 4,0? G/ml (s). Sample e: growth on vre agar after 48 h incubation, vitek 2 susceptible (mic 1) no etest result. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00212 |
| MDR Report Key | 6749768 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-28 |
| Date of Report | 2017-09-12 |
| Date Mfgr Received | 2017-08-18 |
| Device Manufacturer Date | 2017-03-21 |
| Date Added to Maude | 2017-07-28 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? VRE ID AGAR |
| Generic Name | CHROMID? VRE ID AGAR |
| Product Code | JSO |
| Date Received | 2017-07-28 |
| Model Number | 43004 |
| Lot Number | 1005580260 |
| Device Expiration Date | 2017-06-06 |
| 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 | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-28 |