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 2017-07-26 for CHROMID? MRSA PLATE 43451 manufactured by Biomerieux Sa.
[81077206]
A customer in (b)(6) notified biom? Rieux of (b)(6) results associated with chromid? Mrsa plate (ref 43451). The customer reported that two (2) of the three (3) cultures have grown on the (b)(6) and there was no growth on the mrsm medial. The patient was isolated with other colonized (b)(6) patients due to this result and may have been exposed to truly (b)(6) patients. There was a delay in reporting results because sensitivity testing and further testing had to be performed due to the discrepant results. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00210 |
| MDR Report Key | 6744542 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-26 |
| Date of Report | 2017-11-21 |
| Date Mfgr Received | 2017-10-31 |
| Device Manufacturer Date | 2017-04-19 |
| Date Added to Maude | 2017-07-26 |
| 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 | 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? MRSA PLATE |
| Generic Name | CHROMID? MRSA PLATE |
| Product Code | JSO |
| Date Received | 2017-07-26 |
| Model Number | 43451 |
| Lot Number | 1005646630 |
| Device Expiration Date | 2017-07-05 |
| 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 | 1. Other | 2017-07-26 |