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 2017-11-14 for CHROMID? MRSA 43451 manufactured by Biom?rieux Sa.
[93167887]
A customer in (b)(6) reported to biom? Rieux an increase in (b)(6) results in association with chromid? Mrsa. Initially, the customer reported the issue involved chromid? Mrsa smart; however, on (b)(6) 2017, the customer reported the product as chromid? Mrsa (lot 1005201380). The customer reported the chromid? Mrsa is mostly used for screening nose and throat cultures, and that detection of a (b)(6) is confirmed by maldi-tof and vitek? 2 ast testing. The customer stated they have recently noticed a decrease in the false positive rate. The customer reported that results were impacted and there has been error in patient treatment along with a delay for reporting results. There is no indication or report from the hospital or treating physician to biom? Rieux that discrepant results led to any adverse event related to a patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00364 |
| MDR Report Key | 7031249 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-14 |
| Date of Report | 2018-02-16 |
| Date Mfgr Received | 2018-01-24 |
| Device Manufacturer Date | 2016-10-05 |
| Date Added to Maude | 2017-11-14 |
| 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 | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 |
| Generic Name | CHROMID? MRSA |
| Product Code | JSO |
| Date Received | 2017-11-14 |
| Catalog Number | 43451 |
| Lot Number | 1005201380 |
| ID Number | 03573026136642 |
| Device Expiration Date | 2016-12-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-11-14 |