BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 2023575 · Received March 18, 2011

    Report

    Report Number
    3002809144-2011-00105
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 23, 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

    (B)(4). CONCOMITANT MEDICAL DEVICE: ARCHITECT I2000SR ANALYZER, LIST # 3M74-01, 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 US CUSTOMER COMPLAINTS FOR ARCHITECT (B)(6) 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 (B)(6) 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 (B)(6) 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 (B)(6) SAMPLES.

    Additional Manufacturer Narrative · 1

    (B)(4), DEVICE MFR. DATE: IN THE PREVIOUS MEDWATCH SUBMISSION, THE DEVICE MFR. DATE FOR ARCHITECT HAVAB-M REAGENT LOT 93794HN00 WAS INCORRECTLY SUBMITTED AS (B)(6) 2010. THE CORRECT DEVICE MFR. DATE WAS (B)(6) 2010 WHICH HAS BEEN CORRECTED IN THIS FOLLOW UP SUBMISSION. TYPE OF REMEDIAL ACTION INITIATED: THE TYPE OF REMEDIAL ACTION TAKEN FOR THIS ISSUE HAS CHANGED FROM A CORRECTION TO A RECALL. THE CUSTOMER ISSUE IS NOW BEING ASSOCIATED WITH REMEDIAL RECALL 3002809144-4/21/11-001-R FOR THE ARCHITECT HAVAB-M REAGENT LOT 93794HN00. THE REMEDIAL ACTION NUMBER WAS CHANGED FROM 2623532-1/4/10-001-C TO 3002809144-4/21/11-001-R TO REFLECT THE CHANGE IN SITE OF MANUFACTURE FOR THE SUSPECT MEDICAL DEVICE AND IT'S ASSOCIATED REMEDIAL ACTION NUMBER, AND THE TYPE OF REMEDIAL ACTION TAKEN BY ABBOTT.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED INCREASED (B)(6) GRAY ZONE PATIENT RESULTS GENERATED FROM TWO ARCHITECT I2000SR ANALYZERS WHEN (B)(6) REAGENT LOT 93794HN00 WAS IN USE. THE CUSTOMER FURTHER STATED THE GRAY ZONE RESULTS DO NOT FIT THE CLINICAL PICTURE. THE CUSTOMER PROVIDED CALIBRATOR AND CONTROL CHARTS WHICH SHOWED A SLIGHT SHIFT UP IN THE (B)(6) CONTROL. THE CUSTOMER STATED GRAY ZONE RESULTS WERE RARE WITH THE PREVIOUS LOT OF REAGENT AND NOW THEY OBSERVE UP TO FOUR GRAY ZONE RESULTS IN ONE DAY. THE CUSTOMER PROVIDED AN EXAMPLE OF A GRAY ZONE RESULT AS FOLLOWS: SAMPLE 12 INITIAL RESULT: 0.80 S/CO. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER WHETHER REPEAT TESTING WAS PERFORMED TO DETERMINE IF THE GRAY ZONE RESULT WAS CONFIRMED GRAY ZONE OR NON-REACTIVE. THERE WAS NO KNOWN 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 I2000SR ANALYZER, LIST # 3M74-01| ARCHITECT I2000SR ANALYZER, LIST # 3M74-01