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 2017-05-17 for API? 20 STREP 20600 manufactured by Biomerieux Sa.
[75519098]
A customer in france notified biom? Rieux of discrepant results associated with api? 20 strep. The customer reported that the api? 20 strep test gave a false identification. The false identification of aerococcus viridans was reported to the clinician. There was no injury to patient due to the false identification, however there was a delay greater than 24 hours because the first identification was performed on vitek? Ms and then subsequent testing on the api? 20 strep strip. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00124 |
| MDR Report Key | 6572875 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-17 |
| Date of Report | 2017-08-23 |
| Date Mfgr Received | 2017-07-28 |
| Device Manufacturer Date | 2015-12-14 |
| Date Added to Maude | 2017-05-17 |
| 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 | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX S.A. |
| 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 | API? 20 STREP |
| Generic Name | API? 20 STREP |
| Product Code | JSS |
| Date Received | 2017-05-17 |
| Model Number | 20600 |
| Lot Number | 1004525130 |
| Device Expiration Date | 2016-12-13 |
| 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 | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-17 |