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 2017-12-21 for API? RAPID ID 32 STREP 32600 manufactured by Biomerieux, Sa.
[96066917]
A customer in (b)(6) notified biom? Rieux of misidentifications for blood culture isolates from two patients in association with api? Rapid id 32 strep (lot 1005704650) test strip. The customer reported the api? Test was performed from columbia blood agar, and an identification of enterococcus gallinarum was obtained twice with the api? Test strip. Testing was also performed with vitek? 2 and vitek? Ms, and both identified enterococcus faecium (99. 9%). The customer stated an identification of enterococcus faecium was reported to the physician. The customer reported there was no impact to patient results or treatment, and there was no delay for reporting results. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00476 |
| MDR Report Key | 7138768 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-21 |
| Date of Report | 2018-05-07 |
| Date Mfgr Received | 2018-04-12 |
| Device Manufacturer Date | 2017-05-31 |
| Date Added to Maude | 2017-12-21 |
| 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 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 | 2017-12-21 |
| Catalog Number | 32600 |
| Lot Number | 1005704650 |
| ID Number | 03573026066536 |
| Device Expiration Date | 2018-05-31 |
| 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, 38390 FR 38390 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-21 |