BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 2003123 · Received February 28, 2011

    Report

    Report Number
    3002809144-2011-00025
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Report Date
    February 9, 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 (B)(4) ANALYZER, LIST # 3M74-02, SERIAL # (B)(4). EVALUATION. 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 (B)(6) 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), TYPE OF REMEDIAL ACTION INITIATED:IN THE PREVIOUS SUBMISSION, THE TYPE OF REMEDIAL ACTION WAS SUBMITTED AS A PRODUCT CORRECTION. THE TYPE OF REMEDIAL ACTION TAKEN BY ABBOTT WAS A RECALL.

    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 10/8/10. THE CORRECT DEVICE MFR. DATE WAS 11/24/10 WHICH HAS BEEN CORRECTED IN THIS FOLLOW UP SUBMISSION. THE CUSTOMER'S ISSUE IS NOW BEING ASSOCIATED WITH REMEDIAL CORRECTION NUMBER 3002809144-4/21/11-001-R FOR ARCHITECT HAVAB-M REAGENT LOT 93794HN00. THE REMEDIAL CORRECTION NUMBER HAS BEEN 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 ITS ASSOCIATED REMEDIAL ACTION NUMBER FOR THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A HIGHER INCIDENCE OF (B)(6) GREY ZONE RESULTS GENERATED FROM THE ARCHITECT ANALYZER WHEN ARCHITECT (B)(6) REAGENT LOT 93794HN00 WAS IN USE. THE CUSTOMER WOULD TYPICALLY OBSERVE THREE GRAY ZONE RESULTS IN A MONTH AND STATED TWO WERE GENERATED IN ONE NIGHT. THE CUSTOMER ALSO NOTICED MORE GREY ZONE RESULTS WERE GENERATED WHEN THE CALIBRATION IS AT THE LOWER END, THEREFORE, THE CUSTOMER REQUESTED A NEW LOT OF REAGENT. IN ADDITION, THE ABBOTT CUSTOMER TECHNICAL ADVOCATE REVIEWED THE RECOMMENDATIONS OF THE (B)(6) PRODUCT INFORMATION LETTER WITH THE CUSTOMER. AN EXAMPLE OF A GRAY ZONE RESULT IS AS FOLLOWS: INITIAL RESULT: 1.8 S/CO, REPEAT: NON-REACTIVE (NO DATA PROVIDED). THE CUSTOMER RE-ASSAYED THE GRAY ZONE SAMPLES WITH NEW REAGENT AND RESULTS WERE NON-REACTIVE, QUALITY CONTROL PERFORMANCE WAS BETTER AND RELATIVE LIGHT UNITS (RLU) ARE UP. 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 (B)(4) ANALYZER, LIST # 3M74-02| ARCHITECT (B)(4) ANALYZER, LIST # 3M74-02| ARCHITECT (B)(4) ANALYZER, LIST # 3M74-02