BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 2101747 · Received May 25, 2011

    Report

    Report Number
    3002809144-2011-00318
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 21, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICE: ARCHITECT I2000 ANALYZER, LIST # 3M74-01, SERIAL # (B)(4). RESULTS: CROSS CONTAMINATION WAS IDENTIFIED AS A POTENTIAL CAUSE. CONCLUSION: (B)(4). 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 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 (B)(6) SAMPLES LEAVING THE ASSAY PRONE FOR FALSE (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 CONTACTED ABBOTT REGARDING AN INITIAL DISCREPANT ARCHITECT HAVAB-M (B)(6) PATIENT RESULT OF (B)(6) GENERATED WITH REAGENT LOT 93794HN00. THE CUSTOMER STATED TESTING OF THE SAME PATIENT SAMPLE WITH THE ABBOTT CORE-M, HEPATITIS B SURFACE ANTIGEN AND ANTI-HCV ASSAYS GENERATED (B)(6) RESULTS, HOWEVER, THE HAVAB-M (B)(6) RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER WAS ADVISED TO RE-TEST THE SAMPLE WITH A DIFFERENT LOT OF REAGENT AND A (B)(6) RESULT OF (B)(6) WAS GENERATED, THEREFORE, THE CUSTOMER SENT A CORRECTED REPORT. 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 I2000 ANALYZER, LIST # 3M74-01