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 2018-04-20 for API? RAPID ID 32 STREP 32600 manufactured by Biomerieux Sa.
[106271487]
A customer in (b)(6) contacted biom? Rieux to report the occurrence of misidentification of enterococcus faecium as enterococcus gallinarum in association with the api? Rapid id 32 strep test. The customer stated that testing via api? 20 strep, vitek? Ms and vitek? 2 obtained the expected result of enterococcus faecium. There was no indication or report from the laboratory that the discrepant results led to any adverse event related to a patient's state of health. Culture submittal was requested by biom? Rieux for internal investigation. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00055 |
| MDR Report Key | 7447656 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-20 |
| Date of Report | 2018-08-01 |
| Date Mfgr Received | 2018-07-10 |
| Device Manufacturer Date | 2017-09-26 |
| Date Added to Maude | 2018-04-20 |
| 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 | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD |
| Manufacturer City | LA BALME LES GROTTES ISERE, 38390 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | API? RAPID ID 32 STREP |
| Generic Name | API? RAPID ID 32 STREP |
| Product Code | JTO |
| Date Received | 2018-04-20 |
| Catalog Number | 32600 |
| Lot Number | 1005991890 |
| Device Expiration Date | 2018-09-26 |
| 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 | 3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE 383, FRANCE FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-20 |