BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS ANALYZER

    MDR report key: 6828615 · Received August 29, 2017

    Report

    Report Number
    3002769706-2017-00260
    Event Type
    Malfunction
    Date Received
    August 29, 2017
    Report Date
    November 3, 2017
    Manufacturer
    BIOMERIEUX ITALIA
    Product Code
    GQW
    PMA / PMN Number
    K891385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOM¿RIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: FOLLOWING THE INITIAL REPORT BY THE CUSTOMER, BIOM¿RIEUX REQUESTED A SAME DAY RETROSPECTIVE ANALYSIS FROM THE CUSTOMER TO BE DONE BETWEEN THE LAST CONFORMING QCV ((B)(6) 2017) AND THIS QCV FAILURE ((B)(6) 2017). THE RETROSPECTIVE ANALYSIS SHOWED THAT 6 SAMPLES WERE RUN ON THE A3 POSITION. ALL THESE SAMPLES WERE REPEATED IN A DIFFERENT SECTION: 3 SAMPLES WERE REPEATED AS NEGATIVE (NO CHANGE OF RESULT). 3 SAMPLES RESULTS CHANGED TO POSITIVE. HOWEVER, THE CUSTOMER REPORTED THAT THE PHYSICIAN WAS NOTIFIED, AND NO HARM WAS DONE TO THE PATIENT, AS THEY DID NOT RECEIVE THE VZG SHOT BASED ON THE INCORRECT RESULT. THE CUSTOMER STATED THAT THERE WAS NO DELAY IN REPORTING THE RESULTS. CUSTOMER STATED THE RETROSPECTIVE ANALYSIS SHOWED THAT ONLY THOSE 6 SAMPLES LISTED ABOVE WERE THE ONES THAT WERE RAN IN POSITION A3 DURING THE 5 MONTH PERIOD. THE FIELD SERVICE ENGINEER WENT TO THE CUSTOMER SITE TO SERVICE THE INSTRUMENT, AND CONFIRMED A CLOG WAS IN THE A3 POSITION WITH A PUMP TESTER. THE CLOG WAS REMOVED, AND THE INSTRUMENT WAS REPAIRED AND QUALIFIED BY PERFORMING AN OPT TEST AND A QCV TEST, WHICH RESULTED IN VALUES THAT CONFORMED FOR ALL POSITIONS. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THE INCORRECT NEGATIVE RESULTS AND THE QCV FAILURE IN POSITION A3 WAS A CLOG.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOM¿RIEUX OF FALSE NEGATIVE VARICELLA-ZOSTER VIRUS (VZV) RESULTS IN ASSOCIATION WITH VIDAS¿ ANALYZER. THE CUSTOMER TESTED THREE SAMPLES AND RECEIVED NEGATIVE RESULTS FOR EACH ONE. THEY RETESTED THEM IN ANOTHER SECTION OF THE VIDAS¿ INSTRUMENT, AND TWO OF THE SAMPLES RESULTED AS POSITIVE. QCV WAS RUN TWICE AND FAILED EACH TIME. CUSTOMER WAS ASKED TO PERFORM A RETROSPECTIVE ANALYSIS SINCE LAST CORRECT QCV RESULT. THE ANALYSIS FOUND THREE SAMPLES, INITIALLY RESULTED AS NEGATIVE, THAT RESULTED AS POSITIVE AFTER RETESTING. THE PHYSICIAN HAD BEEN NOTIFIED OF THE INCORRECT RESULT, BUT THE PATIENT DID NOT RECEIVE THE VARICELLA IMMUNOGLOBULIN SHOT BASED ON THE INCORRECT RESULT. CUSTOMER STATES THAT WRONG RESULTS WERE REPORTED TO A PHYSICIAN, BUT THAT NO INCORRECT TREATMENT HAD BEEN GIVEN TO THE PATIENT. CUSTOMER STATES THERE WAS NO DELAY IN REPORTING PATIENT RESULTS, AND THERE WAS NO PATIENT HARM. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOM¿RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608077 VIDAS ANALYZER VIDAS® ANALYZER GQW BIOMERIEUX ITALIA W2205
    608078 VIDAS ANALYZER VIDAS® ANALYZER --- BIOMERIEUX ITALIA W2205

    Patients

    Seq Age Sex Outcome Treatment
    1