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 2018-11-19 for API? 20 STREP 20600 manufactured by Biomerieux, Sa.
[129301511]
A customer in (b)(6) reported a misidentification of an enterococcus gallinarum survey sample (cqe ecbu 2018-3a prospective biology 11. 1646 ) as enterococcus faecium in association with the api? Strep test strip. The customer repeated the test several times with several lots and from different culture media, and obtained the same result. The quality control was conforming. There was no patient involvement as the event pertained to a survey sample. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00242 |
| MDR Report Key | 8087036 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-19 |
| Date of Report | 2019-02-11 |
| Date Mfgr Received | 2019-01-14 |
| Device Manufacturer Date | 2018-02-05 |
| Date Added to Maude | 2018-11-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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? 20 STREP |
| Generic Name | API? 20 STREP |
| Product Code | JTO |
| Date Received | 2018-11-19 |
| Catalog Number | 20600 |
| Lot Number | 1006278700 |
| Device Expiration Date | 2019-02-01 |
| 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 | 2018-11-19 |