BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT

    MDR report key: 7982341 · Received October 18, 2018

    Report

    Report Number
    1950204-2018-00437
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Report Date
    January 3, 2019
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED WHEN A CUSTOMER REPORTED A MISIDENTIFICATION OF KLEBSIELLA PNEUMONIAE AS METHYLOBACTERIUM SPP OR UNIDENTIFIED WHEN USING THE VITEK 2 GN CARD LOT # 2410348203 AND USING VITEK 2 SOFTWARE VERSION 8.01. THE STRAIN WAS FROM AN EQA SURVEY AND IDENTIFIED BY MALDI (BRUKER). STRAIN AND RAW DATA NOT AVAILABLE. THE CUSTOMER REPORTED SETTING UP THE STRAIN FROM COLUMBIA BLOOD AGAR THAT INCUBATED FOR 20+/-2 HRS AT 37C. MCFARLAND WAS PREPARED WITHIN RANGE AND SALINE WAS STERILE. THE LAST PM OF THE SYSTEM HAD BEEN PERFORMED IN JAN-2018 AND NOT DUE UNTIL JAN-2019; HOWEVER, A PM WAS PERFORMED ON THE SYSTEM AT THE TIME OF THE COMPLAINT INVESTIGATION, AND ALL ISSUES WERE RESOLVED. TWO LAB REPORTS WERE SUBMITTED SHOWING A RESULT OF NON OR LOW REACTIVE BIOPATTERN. ONE LAB REPORT HAD NO POSITIVE REACTIONS, AND THE OTHER ONLY HAD ONE POSITIVE REACTION. THERE WERE 30 ATYPICAL NEGATIVE REACTIONS (ADO, PYRA, DCEL, BGAL, DGLU, GGT, BGLU, DMAL, DMAN, BXYL, PROA, PLE, TYRA, URE, DSOR, SAC, DTRE, CIT, MNT, LLATK, SUCT, AGAL, PHOS, GLYA, LDC, LHISA, O129R, LMLTA, LLATA) FOR AN IDENTIFICATION OF K. PNEUMONIAE ACCORDING TO THE GN KNOWLEDGE BASE. TWO LAB REPORTS WERE SUBMITTED SHOWING AN IDENTIFICATION OF METHYLOBACTERIUM SPP. BOTH LAB REPORTS HAD ONLY ONE POSITIVE REACTION. THERE WERE 29 ATYPICAL NEGATIVE REACTIONS (ADO, PYRA, DCEL, BGAL, DGLU, GGT, BGLU, DMAN, BXYL, PROA, PLE, TYRA, URE, DSOR, SAC, DTRE, CIT, MNT, LLATK, SUCT, AGAL, PHOS, GLYA, LDC, LHISA, O129R, LMLTA, LLATA) FOR AN IDENTIFICATION OF K. PNEUMONIAE ACCORDING TO THE GN KNOWLEDGE BASE. ATYPICAL NEGATIVE REACTIONS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USER SET UP ERROR OR AN ATYPICAL STRAIN. SINCE THE ISSUE CORRECTED UPON PM OF THE INSTRUMENT, IT APPEARS THAT THE INSTRUMENT CONTRIBUTED TO THE MISIDENTIFICATION. HOWEVER, WITHOUT THE STRAIN OR RAW DATA, IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. THE VITEK 2 GN ID CARD LOT# 2410348203 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS FOR A KLEBSIELLA PNEUMONIAE EQA STRAIN WHEN TESTING WITH THE VITEK® 2 GN ID TEST KIT (REF 21341). THE GN CARD PROVIDED NO IDENTIFICATION (NON-REACTIVE BIOPATTERN) AND THEN AN INCORRECT IDENTIFICATION (METHYLOBACTERIUM SPP.). THE STRAIN WAS RETESTED USING BRUKER MALDI-TOF AND IDENTIFIED AS KLEBSIELLA PNEUMONIAE. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822990 VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX INC. 2410348203 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1