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 2018-10-15 for VITEK? 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT 21342 manufactured by Biomerieux Inc..
[126102624]
A customer in the united states contacted biom? Rieux to report the occurrence of a misidentification of cap survey enterococcus faecium ((b)(4)) as enterococcus gallinarum in association with the vitek? 2 gram positive (gp) identification (id) test kit. There is no indication or report from the laboratory or a physician 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 requested strain submittal from the customer; however, the strain is no longer available. A biom? Rieux internal investigation has been initiated and will use biom? Rieux's internal cap survey strain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00432 |
| MDR Report Key | 7966951 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-15 |
| Date of Report | 2018-12-26 |
| Date Mfgr Received | 2018-11-29 |
| Device Manufacturer Date | 2017-12-02 |
| Date Added to Maude | 2018-10-15 |
| 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 | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOMERIEUX INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS 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 | 2018-10-15 |
| Catalog Number | 21342 |
| Lot Number | 2420554103 |
| Device Expiration Date | 2019-06-03 |
| 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 INC. |
| Manufacturer Address | 595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-15 |