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..
[112152023]
A customer in (b)(6) contacted biomerieux to report a misidentification of streptococcus dysgalactiae as streptococcus pseudoporcinus in association with the vitek? 2 gram-positive (gp) identification (id) test kit. The customer stated the isolate was obtained from a milk sample. Milk source not provided; however, this customer is a veterinary site. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to the patient's (animal) state of health. 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 | 1950204-2018-00226 |
| MDR Report Key | 7601558 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-14 |
| Date of Report | 2018-10-29 |
| Date Mfgr Received | 2018-10-01 |
| 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 |