BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 1854416 · Received October 5, 2010

    Report

    Report Number
    2623532-2010-00074
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS INT'L, LTD
    Product Code
    LOL
    PMA / PMN Number
    N/A
    Removal / Correction Number
    2623532-1/4/10-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CROSS CONTAMINATION WAS IDENTIFIED AS A POTENTIAL CAUSE. (B)(4). AN ADVERSE TREND IN US CUSTOMER COMPLAINTS FOR ARCHITECT HAVAB-IGM ASSAY (LIST NUMBER 6L21) REGARDING HIGHER THAN USUAL GRAYZONE/REACTIVE (GZ/R) RESULTS RATE WAS DETECTED ON MARCH, 2009. THE INVESTIGATION REVEALED THE MOST PROBABLE CAUSE FOR THE INCREASE RATE OF GZ/R RESULTS IS THE HAV ANTIGEN (B)(4) WHICH HAS A REDUCED POTENCY THAT AFFECTS THE ARCHITECT HAVAB-IGM PERFORMANCE. (B)(4). AS A RESULT, THE SIGNAL TO NOISE RATIO IS SHIFTED SPECIALLY IN THE NEGATIVE SAMPLES LEAVING THE ASSAY PRONE FOR FALSE GRAYZONE/REACTIVE RESULTS AND INCREASED ARCH HAVAB-IGM ASSAY SUSCEPTIBILITY TO REAGENT CROSS CONTAMINATION AND TEST SYSTEM VARIABILITY. AS A PREVENTIVE MEASURE TO PROTECT THE INTEGRITY OF TEST RESULTS, CUSTOMERS WERE INSTRUCTED BY A PRODUCT INFORMATION LETTER TO FOLLOW AN ALTERNATIVE PROCESSING METHOD BY SEGREGATING ALL HAVAB-IGM SAMPLES.

    Description of Event or Problem · 1

    THE CUSTOMER FOUR SAMPLES GENERATED ARCHITECT HAVAB-IGM RESULTS OF (B)(6) AND WERE (B)(6) ON THE AXSYM. CURRENT INFORMATION INDICATES (B)(6) PATIENT RESULTS, OR (B)(6) QUALITY CONTROL RESULTS FOR ARCHITECT HAVAB-IGM MAY OCCUR WHEN THE ASSAY IS RUN DIRECTLY FOLLOWING THE ARCHITECT AUSAB ASSAY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HAVAB IGM REAGENT FOR THE DETECTION OF IGM ANTIBODIES TO HEPATITIS A VIRUS LOL ABBOTT DIAGNOSTICS INT'L, LTD 89235Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR, LN3M74-01, (B)(4)