BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM

    MDR report key: 2142052 · Received June 28, 2011

    Report

    Report Number
    3002809144-2011-00509
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    April 27, 2011
    Report Date
    June 3, 2011
    Manufacturer
    ABBOTT GERMANY
    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 I1000SR ANALYZER, LIST # 1L86-01, 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.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, THE CUSTOMER'S ISSUE IS NOT ASSOCIATED WITH REMEDIAL RECALL 2623532-1/4/10-001-C AND IS UNASSIGNED FROM THAT REMEDIAL ACTION.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED NINE OCCURRENCES OF ARCHITECT HAVAB-M (B)(6) RESULTS (NO DATA PROVIDED BY THE CUSTOMER) WHEN REAGENT LOT 95989HN00 WAS IN USE. THE HAVAB-M ASSAY CALIBRATION AND QUALITY CONTROLS WERE OK. THE CUSTOMER REPLACED THE REAGENT AND RE-RAN THE NINE (B)(6) SAMPLES AND OBTAINED (B)(6) RESULTS THAT WERE CONSISTENT WITH EXPECTATIONS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HAVAB IGM LOL ABBOTT GERMANY 95989HN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT (B)(4) ANALYZER, LIST # (B)(4)| ARCHITECT (B)(4) ANALYZER, LIST # (B)(4)