BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 2093772 · Received May 18, 2011

    Report

    Report Number
    3002809144-2011-00304
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ABBOTT
    Product Code
    LOL
    PMA / PMN Number
    K063329
    Removal / Correction Number
    3002809144-4/21/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL IDENTIFIER(S): = (B)(4). CONCOMITANT MEDICAL DEVICE: ARCHITECT I2000 ANALYZER, LIST # 3M74-01, SERIAL # (B)(4). EVALUATION RESULTS: CROSS CONTAMINATION WAS IDENTIFIED AS A POTENTIAL CAUSE. CONCLUSION: (B)(4) MANUFACTURING PROCESS. AN ADVERSE TREND IN US CUSTOMER COMPLAINTS FOR ARCHITECT HAVAB-IGM ASSAY (LIST NUMBER 6L21) REGARDING HIGHER THAN USUAL GRAYZONE/(B)(6) RESULTS RATE WAS DETECTED ON MARCH, 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. (B)(4). AS A RESULT, THE SIGNAL TO NOISE RATIO IS SHIFTED SPECIALLY IN THE NEGATIVE SAMPLES LEAVING THE ASSAY PRONE FOR FALSE GRAYZONE/(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

    IN PREVIOUSLY REPORTED COMPLAINT (B)(4), THE CUSTOMER OBSERVED AN INCREASE IN ARCHITECT HAVAB-M GRAY ZONE PATIENT RESULTS WHICH REPEATED GRAY ZONE FOR SUSPECT ARCHITECT HAVAB-M REAGENT LOT 93794HN00. THE CUSTOMER WAS SENT A DIFFERENT LOT OF REAGENT AS A REPLACEMENT. PRIOR TO THE RECALL OF REAGENT LOT 93794HN00, THE CUSTOMER SWITCHED BACK TO THIS SUSPECT LOT OF REAGENT AND OBSERVED 10 GRAY ZONE RESULTS WHICH WERE REPORTED TO THE CUSTOMER'S STATE HEALTH DEPARTMENT. THE CUSTOMER WAS SENT A REPLACEMENT REAGENT LOT AND DISCARDED THE REMAINDER OF THE SUSPECT REAGENT LOT. THE CUSTOMER PROVIDED AN EXAMPLE OF THE ARCHITECT HAVAB-M GRAY ZONE RESULT AS FOLLOWS: SAMPLE ID (B)(6) INITIAL RESULT: (B)(6). THE CUSTOMER DID NOT PROVIDE ADDITIONAL CONFIRMATION TESTING DATA OF THE GRAY ZONE RESULT. 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 93794HN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR ANALYZER, LIST # 3M74-01