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.
[81608789]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[81608790]
A customer in (b)(6) notified biom? Rieux of breakthrough growth of cefotoxitin sensitive staphylococcus aureus growing on chromid? Mrsa media plate, lot 1005646630 after 48 hours of incubation. Customer stated that there were no patient results affected, wrong results reported to a physician, incorrect treatment provided or harm to a patient. Customer states that there was a > 24 hour delay in reporting results. There is no indication or report from the laboratory that this discrepant result led to any adverse event related to any patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00218 |
| MDR Report Key | 6758373 |
| 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 |