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 2018-01-04 for CHROMID? MRSA SMART 413051 manufactured by Biom?rieux Sa.
[97478801]
A customer from (b)(6) reported to biom? Rieux a false negative result for a (b)(6) strain on a chromid? Mrsa smart (lot 1006023560) plate. The customer stated a specific strain of staphylococcus aureus did not grow on the chromid? Mrsa smart plate. The strain was cultured on chromid? Mrsa smart, chromid? S. Aureus elite, and blood agar. The s. Aureus only grew on the blood agar. The customer then performed disc testing and found the strain to be cefoxitin resistant. It was then cultured from the original sample tube to a new mrsa smart plate and a bd chromagar mrsa plate, and there was no growth on the mrsa smart plate and full growth on the chromagar mrsa plate. 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 | 3002769706-2018-00002 |
| MDR Report Key | 7164052 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-04 |
| Date of Report | 2018-06-20 |
| Date Mfgr Received | 2018-06-08 |
| Device Manufacturer Date | 2017-10-12 |
| Date Added to Maude | 2018-01-04 |
| 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 |
| Generic Name | CHROMID? MRSA SMART |
| Product Code | JSO |
| Date Received | 2018-01-04 |
| Catalog Number | 413051 |
| Lot Number | 1006023560 |
| ID Number | 03573026390815 |
| Device Expiration Date | 2017-12-21 |
| 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 | 2018-01-04 |