BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDAS® LYME IGG

    MDR report key: 6155090 · Received December 8, 2016

    Report

    Report Number
    3002769706-2016-00505
    Event Type
    Injury
    Date Received
    December 8, 2016
    Report Date
    March 20, 2017
    Manufacturer
    BIOMERIEUX, S.A.
    Product Code
    LSR
    PMA / PMN Number
    K122986
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION: THE ANALYSIS OF THE BATCH HISTORY RECORD VIDAS LYME IGG LOT 1005029860 /170708-0 SHOWED NO ANOMALY DURING THE CONTROL LINKED TO THE CUSTOMER'S ISSUE. THE QUALITY PRODUCT LABORATORY TESTED FIVE (5) SAMPLES ON THE RETAIN KIT LOT 170708-0 AND LOT 171116-0 (ANOTHER BATCH WITH DIFFERENT RAW MATERIALS): TARGET: VT : 0.73VT,1.58 VT,0.82 VT,0.6 VT AND 0.02 VT. THE ANALYSIS OF CONTROL CARD SHOWED THAT THE VIDAS LYME IGG LOT 1005029860 /170708-0 WAS IN THE TREND OF THE OTHER OBSERVED BATCHES. ALL THE SAMPLES RESULTS WERE WITHIN THE EXPECTED SPECIFICATIONS ON THE 2 TESTED BATCHES (LOTS 170708-0, AND 171116-0). THE QUALITY PRODUCT LABORATORY DID NOT OBSERVED ANY EVOLUTION OF VIDAS LYME IGG LOT 1005029860 /170708-0 SINCE IT RELEASE ON JULY 27TH 2016. THE BOTH RETURN SAMPLE (AP AND WN) WERE TESTED ON VIDAS LYM IGG LOT 170708-0 (CUSTOMER BATCH) AND LOT 171116-0 (ANOTHER BATCH WITH DIFFERENT RAW MATERIALS) AND VIDAS LYM IGM LOT 170208-0. VIDAS LYM IGG LOT 170708-0: WN : 0.04 VT: NEGATIF, AP : 0.02 VT: NEGATIF. VIDAS LYM IGG LOT 171116-0: WN : 0.05 VT: NEGATIF, AP: 0.02 VT: NEGATIF. VIDAS LYM IGM LOT 170208-0: WN : 0.01 VT: NEGATIF, AP: 0.06 VT: NEGATIF. ALL THE RESULTS ARE CONFIRMED NEGATIVE. THE QUALITY PRODUCT LABORATORY HAD TESTED BOTH THE RETURN SAMPLE (AP AND WN) WITH BIOSYNEX (WESTERN BLOT TECHNIQUE). THE RESULTS WERE FOUND NEGATIVE IN LYME IGG. MOREOVER THE SAMPLE AP WERE TESTED WITH DIASORIN LIA LYME IGM AND IGG , IN LYME IGG: AP RESULTS: <5 UA/ML: NEGATIVE RESULT ; RANGE :>14 UA/ML POSITIVES RESULTS IN LYME IGM: AP RESULTS:12 UA/ML: NEGATIVE RESULT; RANGE:>21 UA/ML POSITIVE RESULTS. THE RESULTS WERE FOUND NEGATIVE ON LYME IG AND IGM. THE SECOND SAMPLE WN CAN'T BE TESTED FOR A LACK OF VOLUME. THE RESULTS OBTAINED IN DIASORIN LYME IGG AND IN BIOSYNEX IGG ARE IN ACCORDANCE WITH VIDAS METHOD. DIASORIN (OTHER EIA TECHNIQUE) CONFIRMS THE NEGATIVE RESULT OBTAINED WITH VIDAS LYME IGG. BIOSYNEX CONFIRMS ONLY P41 BAND, NO OTHER BAND ARE PRESENT, THE RESULT OF THE WESTERN BLOT IS NEGATIVE AS VIDAS LYME IGG RESULTS. THE PERFORMANCE OF VIDAS LYME IGG LOT 1005029860 /170708-0 ARE WITHIN EXPECTED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN POLAND NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS ASSOCIATED WITH VIDAS® LYME IGG ASSAY (REFERENCE (B)(4)) RELATED TO A PATIENT SAMPLE. THE CUSTOMER REPORTED THE MALE PATIENT WAS BITTEN BY A TICK IN (B)(6) 2015. ERYTHEMA MIGRAINES WERE OBSERVED, BUT NOT CHARACTERISTIC. THE PATIENT WAS NOT TREATED. THE PATIENT WAS TESTED USING VIDAS® LYME IGG ON (B)(6) 2015 AND THE RESULT WAS NEGATIVE (0.03). THE PATIENT HAD NEUROLOGICAL SYMPTOMS BUT WAS NOT TREATED FOR BORRELIOSIS, BECAUSE OF THE NEGATIVE TEST RESULT. DUE TO WORSENING SYMPTOMS THE PATIENT WAS TESTED AGAIN (B)(6) 2016 ON VIDAS® LYME IGG AND THE RESULT WAS NEGATIVE. TO CONFIRM THE RESULT, THE CUSTOMER PERFORMED WB TEST AND RECEIVED A POSITIVE RESULT ON WB IGG. AT PRESET, THE PATIENT IS IN THE HOSPITAL OF INFECTIOUS DISEASES WITH SYMPTOMS OF ADVANCED LATE NEUROBORRELIOSIS. THE CUSTOMER REPORTED A CONCERN ABOUT THE DISCREPANCY OF THE RESULTS BETWEEN VIDAS® LYME IGG AND WE AND CHECKED ANOTHER POSITIVE SAMPLE ON BOTH ASSAYS. THE RESULT ON VIDAS® LYME IGG WAS NEGATIVE AND POSITIVE ON WB. SAMPLES ARE FROZEN AND AVAILABLE FOR INVESTIGATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805025 VIDAS® LYME IGG VIDAS® LYME IGG LSR BIOMERIEUX, S.A. 1005029860

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention