BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB-M

    MDR report key: 2150733 · Received July 6, 2011

    Report

    Report Number
    3002809144-2011-00514
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ABBOTT GERMANY
    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
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE ARCHITECT HAVAB-M ASSAY GENERATED FOUR (B)(6) RESULTS WHEN RECALLED REAGENT LOT 93794HN00 WAS IN USE. THE CUSTOMER TESTED THESE FOUR SAMPLES WITH THE AXSYM HAVAB-M ASSAY AND (B)(6) RESULTS WERE OBTAINED. THE CUSTOMER STATED THEY HAD FORGOTTEN ABOUT THE PRODUCT RECALL LETTER FOR THE ARCHITECT HAVAB-M REAGENT LOT 93794HN00, DISCARDED IT, AND AGREED TO RE-RUN THE (B)(6) SAMPLES WITH A NEW LOT OF ARCHITECT REAGENT. AFTER THE CUSTOMER RECEIVED THE REPLACEMENT REAGENT LOT AND RE-RAN THE FOUR (B)(6) SAMPLES, (B)(6) RESULTS WERE OBTAINED. THE CUSTOMER PROVIDED AN EXAMPLE OF PATIENT RESULTS AS FOLLOWS: (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HAVAB-M LOL ABBOTT GERMANY 93794HN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR ANALYZER, LIST # 1L86-01