BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB-M

    MDR report key: 2150732 · Received July 6, 2011

    Report

    Report Number
    3002809144-2011-00516
    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

    NO CONSEQUENCES OR IMPACT TO PATIENT. INCORRECT OR INADEQUATE TEST RESULTS. CONCOMITANT MEDICAL DEVICE: ARCHITECT I1000SR ANALYZER, LIST # 1L86-01, SERIAL # (B)(4). 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 U.S. CUSTOMER COMPLAINTS FOR ARCHITECT HAVAB-IGM ASSAY (LIST NUMBER 6L21) REGARDING HIGHER THAN USUAL GRAYZONE/REACTIVE (GZ/R) RESULTS RATE WAS DETECTED ON (B)(6) 2009. THE INVESTIGATION REVEALED THE MOST PROBABLE CAUSE FOR THE INCREASE RATE OF GZ/R RESULTS IS THE HAV ANTIGEN CODE 26286 WHICH HAS A REDUCED POTENCY THAT AFFECTS THE ARCHITECT HAVAB-IGM 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 FALSE GRAYZONE/REACTIVE 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 EQUIVOCAL RESULTS WHEN RECALLED REAGENT LOT 93794HN00 WAS IN USE. THE CUSTOMER TESTED THESE FOUR SAMPLES WITH THE AXSYM HAVAB-M ASSAY AND NEGATIVE 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 EQUIVOCAL SAMPLES WITH A NEW LOT OF ARCHITECT REAGENT. AFTER THE CUSTOMER RECEIVED THE REPLACEMENT REAGENT LOT AND RE-RAN THE FOUR EQUIVOCAL SAMPLES, NEGATIVE RESULTS WERE OBTAINED. THE CUSTOMER PROVIDED AN EXAMPLE OF PATIENT RESULTS AS FOLLOWS: (B)(6) INITIAL RESULT: 0.79 S/CO, REPEAT ON AXSYM: 0.13 S/CO, REPEAT WITH A NEW ARCHITECT LOT: 0.49 S/CO. 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