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 2018-02-09 for CHROMID? VRE AGAR 43004 manufactured by Biom?rieux Sa.
[100124408]
A customer from (b)(6) reported a false resistant result for a vancomycin-susceptible enterococcus faecalis strain from a rectal swab, in association with the chromid? Vre agar. The customer stated the vancomycin-susceptible strain with typical color of vre, exhibited growth on the chromid? Vre agar after 24 hours; organism growth should have been inhibited. The strain was tested with the vitek? 2 ast-p586 card and was vancomycin susceptible (mic=1). The pcr result was van-a/b negative. The customer was not able to retest, as the isolate could not be re-cultivated on a vre plate. The customer reported the initial incorrect result was reported to a physician but was corrected. The customer stated there was no impact to patient treatment. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00014 |
| MDR Report Key | 7260428 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-09 |
| Date of Report | 2018-04-12 |
| Date Mfgr Received | 2018-03-20 |
| Device Manufacturer Date | 2017-12-06 |
| Date Added to Maude | 2018-02-09 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 5, RUE DES AQUEDUCS |
| Manufacturer City | CRAPONNE, FR 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 AGAR |
| Generic Name | CHROMID? VRE AGAR |
| Product Code | JSO |
| Date Received | 2018-02-09 |
| Catalog Number | 43004 |
| Lot Number | 1006145660 |
| ID Number | 03573026257972 |
| Device Expiration Date | 2018-03-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-09 |