BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 2072370 · Received April 29, 2011

    Report

    Report Number
    3002809144-2011-00218
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    March 29, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). ARCHITECT I2000 ANALYZER, LIST # 3M74-01 SERIAL # (B)(4). EVALUATION: 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 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 (B)(6) WHICH HAS A REDUCED POTENCY THAT AFFECTS THE ARCHITECT HAVAB-IGM PERFORMANCE. (B)(4). 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 EXPERIENCED AN INCREASE IN ARCHITECT HAVAB-M GRAY ZONE PATIENT RESULTS WHEN REAGENT LOT 93794HN00 WAS IN USE. THE CUSTOMER STATED 23 GRAY ZONE RESULTS HAD BEEN GENERATED SINCE (B)(6) 201 (NO DATA PROVIDED BY THE CUSTOMER). THE CUSTOMER FOLLOWED THE PACKAGE INSERT RECOMMENDATIONS FOR THE GENERATION OF GRAY ZONE RESULTS AND REPEATED TESTING IN DUPLICATE AFTER CENTRIFUGATION; REPEAT GRAY ZONE RESULTS WERE GENERATED. THERE WAS NO INFORMATION FROM THE CUSTOMER WHETHER THESE GRAY ZONE RESULTS WERE CONFIRMED GRAY ZONE BY ANOTHER METHOD OR LABORATORY. THE CUSTOMER RECEIVED A NEW LOT OF HAVAB-M REAGENT AND THE NEGATIVE QUALITY CONTROL DROPPED BACK DOWN FROM THE PREVIOUS LOT. THE GRAY ZONE RESULTS WERE REPORTED OUT AS GRAY ZONE, HOWEVER, 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 I2000 ANALYZER, LIST # 3M74-01| ARCHITECT I2000 ANALYZER, LIST # 3M74-01