BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® LYME IGG

    MDR report key: 7076042 · Received December 1, 2017

    Report

    Report Number
    3002769706-2017-00390
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Report Date
    March 2, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LSR
    UDI-DI
    03573026458270
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM THE UNITED STATES HAD NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS ASSOCIATED WITH THE VIDAS® LYME IGG II INVOLVING A PATIENT SAMPLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE PATIENT SAMPLE WAS NOT SUBMITTED FOR EVALUATION. THE ANALYSIS OF BATCH HISTORY RECORDS FOR VIDAS LYME IGG II LOT 1005659490 /180710 0 SHOWED NO ANOMALY DURING THE MANUFACTURING AND CONTROL PROCESSES. THE ANALYSIS OF CONTROL CHARTS OF EIGHT (8) INTERNAL SAMPLES, THREE (3) NEGATIVE, FIVE (5) POSITIVE, ON SEVEN (7) VIDAS LYME IGG II BATCHES (INCLUDING LOT MENTIONED BY CUSTOMER) SHOWED THAT ALL THE RESULTS WERE WITHIN SPECIFICATIONS. VIDAS LYME IGG II LOT 1005659490 /180710 0 IS IN THE TREND OF THE OTHER BATCHES. THE COMPLAINT LABORATORY TESTED FIVE (5) INTERNAL SAMPLES (FIVE (5) POSITIVE) ON A RETAINED KIT OF VIDAS LYME IGG II LOT 1005659490 /180710 0 . THE RESULTS OBTAINED WERE WITHIN THE EXPECTED SPECIFICATIONS AND SIMILAR TO THOSE OBTAINED DURING RELEASE. THERE IS NO DRIFT OF VIDAS LYME IGG II LOT 1005659490 /180710 0 SINCE ITS RELEASE. AS IT WAS NOT POSSIBLE TO GET THE SAMPLE, NO FURTHER INVESTIGATION COULD BE PERFORMED. VIDAS LYME IGG II LOT 1005659490 /180710 0 PERFORMED WITHIN THE EXPECTED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS ASSOCIATED WITH THE VIDAS® LYME IGG II INVOLVING A PATIENT SAMPLE. THE CUSTOMER INDICATED RUNNING THE PATIENT SAMPLE AND GETTING NEGATIVE RESULT; HOWEVER, THE SAMPLE WAS SENT TO A REFERENCE LAB WHERE THE WESTERN BLOT WAS POSITIVE FOR MULTIPLE BANDS. THE CUSTOMER REPORTED THE SPECIMEN THEY TESTED AND THE SPECIMEN THE REFERENCE LAB TESTED WERE OBTAINED FROM THE PATIENT AT THE SAME TIME BUT WERE IN DIFFERENT TUBES. SERUM WAS USED FOR BOTH TESTS. THE CUSTOMER INDICATED NEITHER SPECIMEN IS AVAILABLE FOR SUBMISSION TO BIOMÉRIEUX. A BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856016 VIDAS® LYME IGG VIDAS® LYME IGG LSR BIOMERIEUX SA 1005659490 03573026458270

    Patients

    Seq Age Sex Outcome Treatment
    1