BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 2100169 · Received May 24, 2011

    Report

    Report Number
    2623532-2011-00016
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS INT'L, LTD
    Product Code
    LOL
    PMA / PMN Number
    K063329
    Removal / Correction Number
    2623532-1/4/10-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), CONCOMITANT MEDICAL DEVICE: ARCHITECT I2000SR ANALYZER, LIST # 3M74-95, SERIAL # (B)(4). EVALUATION RESULTS: 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 (B)(6) 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 (B)(6) WHICH HAS A REDUCED POTENCY THAT AFFECTS THE ARCHITECT (B)(6) 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 NEGATIVE SAMPLES LEAVING THE ASSAY PRONE FOR (B)(6) RESULTS AND INCREASES ARCH (B)(6) 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 (B)(6) SAMPLES.

    Description of Event or Problem · 1

    THE CUSTOMER NOTICED AN INCREASE IN INITIAL REACTIVE RATES FOR ARCHITECT (B)(6) PATIENT SAMPLES. THE CUSTOMER RECALIBRATED THE ASSAY ON THE ANALYZER WHICH DID NOT RESOLVE THE ISSUE. THE CUSTOMER WAS ADVISED TO PERFORM VARIOUS TROUBLESHOOTING PROCEDURES WHICH RESOLVED THE ISSUE. THE MOST LIKELY CAUSE OF THE INITIAL REACTIVE RATES OBSERVED BY THE CUSTOMER WAS DUE TO THE POOR CONDITION OF THE ANALYZER PROBE OR THE REAGENT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER, LIST # 3M74-95