BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MASS SPECTROMETER

    MDR report key: 7060947 · Received November 27, 2017

    Report

    Report Number
    3002769706-2017-00384
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    May 12, 2017
    Report Date
    January 8, 2018
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    PEX
    UDI-DI
    03573026359119
    PMA / PMN Number
    DEN130013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION:SYSTEM WAS OPERATIONAL DURING THE TEST. THE CUSTOMER DATA WAS ANALYZED AND REPROCESSED WITH VITEK® MS KNOWLEDGE BASE (KB) (B)(4) (FOR CLINIC USE) AND VITEK® MS KB V3.1 (FOR INDUSTRY USE) AND ALL SPOTS GAVE NO IDENTIFICATION. THE WORKFLOW USER MANUAL CLINIC USE REF. 4501-2233 - E, IN THE "VITEK® MS. ACQUISITION/ANALYSIS MESSAGES" SECTION, MENTIONS:"[P150] SAMPLE SPOT: NO IDENTIFICATION - REPEAT THE ACQUISITION FOR THE SAME DEPOSIT. IF THE MESSAGE IS DISPLAYED AGAIN, REDO THE DEPOSIT AND THEN THE ACQUISITION. IF THE MESSAGE IS DISPLAYED AGAIN, REPEAT THE IDENTIFICATION USING ANOTHER METHOD (SUCH AS VITEK® 2, API STRIP, OTHER BIOCHEMICAL OR MOLECULAR METHODS).IMPROVEMENTS HAVE BEEN MADE SINCE KB (B)(4): THE ACCEPTANCE CRITERIA IS MORE STRINGENT (FROM -0.6 WITH KB (B)(4) FOR KB (B)(4).), ALLOWING TO REDUCE THE NUMBER OF IDENTIFICATION ISSUE. THE ACQUISITION METHOD.THE RESULT DISCREPANCIES OBSERVED BETWEEN THE VITEK® MS KB (B)(4) COULD BE EXPLAINED BY THE IMPROVEMENTS LISTED ABOVE.THE SUSPECTED ROOT CAUSE OF THE ISSUE: SYSTEM LIMITATION (REGARDING VITEK MS KB (B)(4)).

    Description of Event or Problem · 1

    ON (B)(6) 2017, A CUSTOMER FROM THE (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION IN ASSOCIATION WITH VITEK® MS INSTRUMENT (REFERENCE (B)(4)). THE CUSTOMER REPORTED THAT ON (B)(6) 2017, AN ISOLATE HAD BEEN IDENTIFIED AS GROUP A STREPTOCOCCUS WITH THE VITEK® MS INSTRUMENT. HOWEVER, A REFERENCE LABORATORY IDENTIFIED THE ISOLATE AS GROUP G STREPTOCOCCUS. NO OTHER METHOD WAS USED TO DETERMINE THE CORRECT IDENTIFICATION OF THE ISOLATE, BUT THE CUSTOMER CONSIDERED THE REFERENCE LABORATORY RESULT TO BE THE CORRECT IDENTIFICATION. THE CUSTOMER STATED THAT THE PATIENT RESULT WAS AFFECTED, AND THE WRONG RESULT WAS REPORTED TO A PHYSICIAN. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING THE RESULT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837832 VITEK MASS SPECTROMETER VITEK® MS¿ PEX BIOMERIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1