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 2018-07-19 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc.

Event Text Entries

[114946267] A customer from (b)(6) reported misidentifications of six (6) acinetobacter baumanni strains as alcaligenes faecalis in association with the vitek? 2 gn test kit. The customer reported that after their vitek system was updated to version 7. 01, identifications of acinetobacter baumanni had stopped appearing in their internal medicine service, and a new species, alcaligenes faecalis sp faecalis, was displayed. The customer realized that the morphology of colonies was not characteristic for alcaligenes spp. , so the strains were sent to an external lab for identification by mass spectrometry. The results were acinetobacter baumanni. Oxidase tests were performed on each strain obtaining a negative result. Acinetobacter baumanni is oxidase negative and alcaligenes spp is oxidase positive. Fresh strains were grown and processed with manual biochemistry and a spectrometer, and results of acinetobacter baumanni were obtained. The local fas/fse conducted additional testing and reported that seven (7) strains provided by the customer were processed in triplicate in the customer's instrument, and six (6) identified as algaligenes faecalis faecalis, and one (1) as acinetobacter baumanni. The strains were processed in three different vitek ms instruments, two vitek 2 instruments and by different users. All strains identified as acinetobacter baumanni with vitek ms and api? 20ne, while vitek 2 identified alcaligenes faecalis. The customer's vitek 2xl was reviewed by two engineers, and updated to version 8. 01. The same strains were processed again, giving acinetobacter baumanni. No patient information was provided by the customer. 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 Number1950204-2018-00264
MDR Report Key7703887
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-07-19
Date of Report2018-09-18
Date Mfgr Received2018-08-22
Device Manufacturer Date2018-04-02
Date Added to Maude2018-07-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. DEBRA BROYLES
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityST. LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147318805
Manufacturer G1BIOMERIEUX, INC
Manufacturer Street595 ANGLUM ROAD
Manufacturer CitySAINT LOUIS 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 Received2018-07-19
Catalog Number21341
Lot Number2410492403
Device Expiration Date2019-04-02
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, INC
Manufacturer Address595 ANGLUM ROAD SAINT LOUIS MO 63042 US 63042


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.