BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® MS INSTRUMENT

    MDR report key: 8544871 · Received April 24, 2019

    Report

    Report Number
    9615754-2019-00032
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Report Date
    June 14, 2019
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    PEX
    UDI-DI
    03573026359119
    PMA / PMN Number
    DEN130013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED FOR A CUSTOMER REPORT OF A MISIDENTIFICATION OF BREVIBACILLUS SPP. AS ESCHERICHIA COLI (E. COLI) IN ASSOCIATION WITH THE VITEK ® MS WHILE TESTING A PHARMACEUTICAL PRODUCT. THE INVESTIGATION INCLUDED ANALYZING THE DATA PROVIDED FROM THE CUSTOMER TESTS PERFORMED. CONCLUSION ON THE SYSTEM: THE CUSTOMER'S SYSTEM WAS AT THE LIMIT DURING THE TESTS. A NEW FINE TUNING WAS RECOMMENDED TO BE SCHEDULED. THE CUSTOMER'S SPOT PREPARATION QUALITY WAS NOT OPTIMAL. THE SAMPLE "ALL PEAKS" VALUES ARE HETEROGENEOUS; THERE IS A HIGH VARIATION. THIS COULD BE EXPLAINED BY A NON-OPTIMAL SPOT PREPARATION OF THE CALIBRATOR STRAIN (CULTURE, SPOT, DIFFERENT OPERATOR...). CONCLUSION ON THE IDENTIFICATION: WITH THE INFORMATION PROVIDED BY THE LOCAL CUSTOMER SERVICE, THE EXPECTED IDENTIFICATION IS UNKNOWN BUT MOST PROBABLY NOT ESCHERICHIA COLI. SUSPECTED CAUSE: LACK OF FINE TUNING MONITORING. NON OPTIMAL SPOT PREPARATION.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF BREVIBACILLUS SPP. AS ESCHERICHIA COLI (E. COLI) IN ASSOCIATION WITH THE VITEK ® MS WHILE TESTING A PHARMACEUTICAL PRODUCT. THE ORIGINAL RESULT WAS A SINGLE PREPARATION WITH A RESULT OF E.COLI (99.9%). THE CUSTOMER NOTICED THAT E.COLI WAS AN ATYPICAL RESULT BASED ON THE MEDIA USED FOR THE SAMPLE AND PERFORMED RETESTING ON THE VITEK MS. THE RETEST SAMPLES WERE PERFORMED IN DUPLICATE YIELDING RESULTS OF BREVIBACILLUS SPP. (99.9%) FOR BOTH SAMPLE PREPARATIONS. THERE IS NO PATIENT ASSOCIATED WITH THIS ISOLATE, THEREFORE THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336706 VITEK® MS INSTRUMENT VITEK® MS INSTRUMENT PEX BIOMERIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1