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 2017-08-01 for CHROMID? MRSA AGAR 43451 manufactured by Biomerieux Sa.
[81632654]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[81632655]
A customer in (b)(6) notified biom? Rieux of (b)(6) growing on chromid? Mrsa media plate, lot 1005646630. This occurred with three specimens after 48 hours of incubation. Further analysis with cefoxitin disc testing confirmed the specimens as susceptible. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health. Per the customer, this result did lead to a delay greater than 24 hours, and wrong results were reported to a physician. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00217 |
| MDR Report Key | 6758371 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-01 |
| Date of Report | 2017-11-21 |
| Date Mfgr Received | 2017-10-31 |
| Device Manufacturer Date | 2017-04-19 |
| Date Added to Maude | 2017-08-01 |
| 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 G1 | BIOMERIEUX SA |
| Manufacturer Street | 5, RUE DES AQUEDUCS |
| Manufacturer City | CRAPONNE, 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 AGAR |
| Generic Name | CHROMID? MRSA AGAR |
| Product Code | JSO |
| Date Received | 2017-08-01 |
| Catalog 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, 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-01 |