VITEK? 2 NH TEST KIT 21346

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 2017-05-08 for VITEK? 2 NH TEST KIT 21346 manufactured by Biomerieux, Inc.

Event Text Entries

[74839700] A customer from the (b)(6)reported to biom? Rieux a misidentification of campylobacter jejuni as neisseria cinerea for nine (9) strains in association with the vitek? 2 nh test kit (udi (b)(4)). The customer reported nine strains were identified as neisseria cinerea with vitek? 2 nh. One of the nine strains was sent to the reference laboratory and was identified as campylobacter jejuni, using the api? System. The customer reported the event did not involve a patient or healthcare provider and did not impact any treatment. 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 Number1950204-2017-00150
MDR Report Key6552365
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-05-08
Date of Report2017-09-11
Date Mfgr Received2017-08-17
Device Manufacturer Date2016-02-19
Date Added to Maude2017-05-08
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 ContactMRS. ELLEN WELTMER
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityST. LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147317301
Manufacturer G1BIOMERIEUX, INC
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityST. LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal Code63042
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITEK? 2 NH TEST KIT
Generic NameVITEK? 2 NH TEST CARD
Product CodeJTO
Date Received2017-05-08
Catalog Number21346
Lot Number245390220
ID Number03573026144357
Device Expiration Date2017-08-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, INC
Manufacturer Address595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-08

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