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 2017-12-05 for CHROMID? MRSA SMART AGAR 413050 manufactured by Biomerieux Sa.
[95768856]
A customer in (b)(6) reported to biom? Rieux discrepant (b)(6) results associated with (b)(6) lot 1005950400. The customer reported that, from (b)(6) 2017 to (b)(6) 2017 they had observed unexpected growth of (b)(6) characteristic colonies on the chromid (b)(6) smart plates for twelve (12) samples. No (b)(6) results (incorrect (b)(6) result) were reported to the physician. The discrepant (b)(6) results did not lead 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 | 3002769706-2017-00393 |
| MDR Report Key | 7083049 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-05 |
| Date of Report | 2018-05-17 |
| Date Mfgr Received | 2018-04-27 |
| Device Manufacturer Date | 2017-09-08 |
| Date Added to Maude | 2017-12-05 |
| 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 | 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 SMART AGAR |
| Generic Name | CHROMID? MRSA SMART AGAR |
| Product Code | JSO |
| Date Received | 2017-12-05 |
| Catalog Number | 413050 |
| Lot Number | 1005950400 |
| Device Expiration Date | 2017-11-17 |
| 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 | 2017-12-05 |