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 2018-06-14 for VITEK? 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT 21342 manufactured by Biomerieux Inc..
[112150210]
A customer in (b)(6) contacted biomerieux to report a misidentification of streptococcus equi ssp equi as streptococcus equi ssp zooepidemicus in association with the vitek? 2 gram-positive (gp) identification (id) test kit. The customer stated the isolate was obtained via abscess swab from a horse. The customer indicated the vitek 2 result was not used in the treatment decisions for the patient. Therefore, there was no adverse impact to the patient (a horse) as a result of vitek 2 testing. Biom? Rieux requested strain submittal from the customer. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00225 |
| MDR Report Key | 7601573 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-14 |
| Date of Report | 2018-10-22 |
| Date Mfgr Received | 2018-09-25 |
| Device Manufacturer Date | 2018-01-20 |
| Date Added to Maude | 2018-06-14 |
| 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 | 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 | 2018-06-14 |
| Catalog Number | 21342 |
| Lot Number | 2420603403 |
| Device Expiration Date | 2019-07-22 |
| 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 | 2018-06-14 |