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 2017-11-21 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux Inc..
[93570921]
A customer in the united states notified biom? Rieux of misidentification results in association with vitek? 2 anc test kit (ref (b)(4)). The customer reported that three patient strains were tested with vitek? 2, which provided identifications of fusobacterium nucleatum. Vitek? Ms was used to test the isolates, and it provided either a "no id" result or campylobacter jejuni result. The state lab identified the strains as campylobacter concisus using the bruker method. Fusobacterium nucleatum was incorrectly reported to the physician for one of the patients. There is no information on reported results for the other two patients. 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. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00415 |
| MDR Report Key | 7050723 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-21 |
| Date of Report | 2018-03-22 |
| Date Mfgr Received | 2018-02-27 |
| Date Added to Maude | 2017-11-21 |
| 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 | 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 ANC TEST KIT |
| Generic Name | VITEK? 2 ANC TEST KIT |
| Product Code | JSP |
| Date Received | 2017-11-21 |
| Catalog Number | 21347 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-11-21 |