VITEK? 2 GN TEST KIT 21341

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number1950204-2018-00311
MDR Report Key7827980
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-08-29
Date of Report2018-10-16
Date Mfgr Received2018-09-18
Device Manufacturer Date2018-04-23
Date Added to Maude2018-08-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. DEBRA BROYLES
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1BIOMERIEUX, INC.
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal Code63042
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITEK? 2 GN TEST KIT
Generic NameVITEK? 2 GN TEST KIT
Product CodeLQM
Date Received2018-08-29
Catalog Number21341
Lot Number2410518203
Device Expiration Date2019-04-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, INC.
Manufacturer Address595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-29

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