BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 1854508 · Received October 5, 2010

    Report

    Report Number
    2623532-2010-00073
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 16, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 (B)(6) RESULTS RATE WAS DETECTED ON (B)(6) 2009. THE INVESTIGATION REVEALED THE MOST PROBABLE CAUSE FOR THE INCREASE RATE OF (B)(6) RESULTS IS THE HAV ANTIGEN CODE 26286 WHICH HAS A REDUCED POTENCY THAT AFFECTS THE ARCHITECT HAVAB-IGM PERFORMANCE. INSUFFICIENT ACTIVE ANTIGEN IS BEING COATED ON THE MICROPARTICLE WITHIN THE CURRENT MICROPARTICLE MANUFACTURING PROCESS RESULTING IN A PERFORMANCE THAT IS CHARACTERIZED BY LOWER CALIBRATOR 1 RELATIVE LIGHT UNITS (RLU) VALUES. AS A RESULT, THE SIGNAL TO NOISE RATIO IS SHIFTED SPECIALLY IN THE (B)(6) SAMPLES LEAVING THE ASSAY PRONE FOR (B)(6) 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 WAS CONCERNED ABOUT THE INCREASE IN THE NUMBER OF (B)(6) ARCHITECT HAVAB-IGM SAMPLES AFTER IMPLEMENTING THE INSTRUCTIONS IN FA30DEC2009. CURRENT INFORMATION INDICATES ELEVATED (B)(6) PATIENT RESULTS, OR ELEVATED OUT OF RANGE HIGH (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 82584Q102

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR, LN 3M74-01, SN (B)(4)