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 2018-09-12 for VITEK? 2 GRAM NEGATIVE IDENTIFICATION TEST KIT 21341 manufactured by Biomerieux Inc..
[120109884]
A customer in (b)(6) contacted biom? Rieux to report a misidentification of serratia marcescens as yersinia pestis for a canine cerebral spinal fluid specimen in association with the vitek? 2 gram negative (gn) identification (id) test kit (card). The yersinia pestis result was obtained via vitek? Ms testing at another laboratory. The isolate was also sent to a second independent laboratory; the isolate was tested with bruker maldi-tof, and also confirmed the id as a serratia marcescens. 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 (canine) 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 | 1950204-2018-00355 |
| MDR Report Key | 7868714 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-12 |
| Date of Report | 2018-11-14 |
| Date Mfgr Received | 2018-10-23 |
| Device Manufacturer Date | 2018-05-12 |
| Date Added to Maude | 2018-09-12 |
| 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 | HAXELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOMERIEUX INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT 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 NEGATIVE IDENTIFICATION TEST KIT |
| Generic Name | VITEK? 2 GN ID TEST KIT |
| Product Code | LQM |
| Date Received | 2018-09-12 |
| Catalog Number | 21341 |
| Lot Number | 2410532203 |
| Device Expiration Date | 2019-05-12 |
| 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 SAINT LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-12 |