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 2018-08-29 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc..
[119499519]
A customer from (b)(6) reported a misidentification of escherichia coli as salmonella enterica spp diarizonae, for an ileum biopsy sample, in association with the vitek? 2 gn test kit. The customer stated the isolate was tested twice from macconkey and blood agars, and identified as salmonella enterica spp diarizonae with the gn card (lot 2410513203). The customer believed these results did not match with the colony appearance that resembled e. Coli, as further culture on xld (xylose lysine deoxycholate) agar, showed growth without pigmentation and serotypting was negative both for h and o antigens. Testing was performed by an external laboratory using maldi-tof and biofire? Fa bcid, and both results were e. Coli. The lab repeated the vitek gn card (lot 2410518203) test and the result was salmonella enterica spp diarizonae. The customer stated the result reported was e. Coli and patient treatment was not impacted. The customer reported a delay of three days between the initial vitek test to the final report. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00311 |
| MDR Report Key | 7827980 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-29 |
| Date of Report | 2018-10-16 |
| Date Mfgr Received | 2018-09-18 |
| Device Manufacturer Date | 2018-04-23 |
| Date Added to Maude | 2018-08-29 |
| 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 | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 GN TEST KIT |
| Generic Name | VITEK? 2 GN TEST KIT |
| Product Code | LQM |
| Date Received | 2018-08-29 |
| Catalog Number | 21341 |
| Lot Number | 2410518203 |
| Device Expiration Date | 2019-04-28 |
| 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 HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-29 |