BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 1894334 · Received November 9, 2010

    Report

    Report Number
    2623532-2010-00079
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Report Date
    September 2, 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
    NY, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: CROSS CONTAMINATION WAS IDENTIFIED AS A POTENTIAL CAUSE. CONCLUSION: INSUFFICIENT ACTIVE ANTIGEN IS BEING COATED ON THE MICROPARTICLE WITH THE CURRENT MICROPARTICLE MANUFACTURING PROCESS. 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 CODE 26286 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 INCREASES 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 STATED THERE WAS AN INCREASE IN (B)(6) RESULTS GENERATED ON THE ARCHITECT I2000SR ANALYZER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. THERE IS A POTENTIAL TO GENERATE (B)(6) OR (B)(6) RESULTS WHEN THE ARCHITECT AUSAB ASSAY PRECEDES (B)(6). A PRODUCT CORRECTION WAS ISSUED AND REPORTED UNDER 21CFR806 TO THE FDA.

    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 88077Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR, LN 3M74-98, (B)(4)