MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-04-20 for VITEK? 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT 21342 manufactured by Biom?rieux, Inc..
[106861972]
A customer in the united states contacted biom? Rieux to report the occurrence of misidentification of streptococcus constellatus (cap survey strain2017 d-17) as streptococcus anginosus in association with the vitek? 2 gp id test kit. Upon notification from cap, the customer repeated the test; obtained a low discrimination identification strep. Anginosus / strep. Constellatus ssp constellatus / strep. Gordonii. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. There was no patient directly associated with the cap survey strain. Biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00154 |
| MDR Report Key | 7448263 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-20 |
| Date of Report | 2018-05-15 |
| Date Mfgr Received | 2018-04-24 |
| Device Manufacturer Date | 2017-09-27 |
| 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 | BIOM |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK? 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT |
| Generic Name | VITEK? 2 GP ID CARD |
| Product Code | LQL |
| Date Received | 2018-04-20 |
| Catalog Number | 21342 |
| Lot Number | 2420488103 |
| Device Expiration Date | 2019-03-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX, INC. |
| Manufacturer Address | 595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-20 |