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 2017-10-26 for CHROMID? MRSA SMART AGAR 413050 manufactured by Biom?rieux Sa.
[91199336]
A customer from (b)(6) notified biom? Rieux of observing discrepant positive results when testing different patients samples for the screening of (b)(6). On (b)(6) 2017, the customer reported that they had tested different patients' samples for (b)(6) screening test using biom? Rieux chromid? (b)(6) smart agar, lot 1005801390 and that after incubation they had obtained a characteristic bacterial growth indicating the sample to be (b)(6) positive. The customer stated that they could confirm that the strains isolated from the concerned patients' samples were s. Aureus meca negative and susceptible to oxacillin antimicrobial agent, which was not consistent with the (b)(6) positive results obtained with the chromid? (b)(6) smart agar. No further detail was provided. The customer did not indicate whether the result was reported to the treating physician or impacted treatment decisions. There is no indication or report from the laboratory to biom? Rieux that the discrepant results led to any adverse event related to the patients' state of health. Though chromid? (b)(6) smart agar (ref. 413050) is not registered, marketed of distributed in the u. S. , a similar product chromid? (b)(6) agar (ref. 43841) is registered in the u. S. Biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00318 |
| MDR Report Key | 6981923 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-26 |
| Date of Report | 2018-05-17 |
| Date Mfgr Received | 2018-04-25 |
| Device Manufacturer Date | 2017-06-28 |
| Date Added to Maude | 2017-10-26 |
| 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? MRSA SMART AGAR |
| Generic Name | CHROMID? MRSA SMART AGAR |
| Product Code | JSO |
| Date Received | 2017-10-26 |
| Catalog Number | 413050 |
| Lot Number | 1005801390 |
| Device Expiration Date | 2017-09-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-26 |