BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 2072368 · Received April 29, 2011

    Report

    Report Number
    3002809144-2011-00219
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    April 1, 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). 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). CONCOMITANT MEDICAL DEVICE: ARCHITECT I2000 ANALYZER, LIST # 3M74-02 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 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 NOTICED AN INCREASE IN ARCHITECT HAVAB-M (B)(6) RESULTS, WHERE SEVEN PATIENT SAMPLES GENERATED INITIAL (B)(6) RESULTS AND REPEATED AS (B)(6) WHEN HAVAB-M REAGENT LOT 93794HN00 WAS IN USE (NO DATA PROVIDED BY THE CUSTOMER). THE CUSTOMER STATED ALL MAINTENANCE WAS CURRENT AND REAGENT PACKAGE INSERT GUIDELINES WERE FOLLOWED. THE CUSTOMER PROVIDED ONE EXAMPLE OF THE (B)(6) PATIENT RESULTS AS FOLLOWS: SAMPLE ID (B)(6) INITIAL RESULT: (B)(6), REPEAT TESTING IN DUPLICATE: (B)(6), RESPECTIVELY. THE CUSTOMER RETESTED FOUR OF THE SEVEN INITIAL (B)(6) PATIENT SAMPLES WITH A NEW LOT OF REAGENT AND OBTAINED (B)(6) RESULTS (NO DATA PROVIDED BY THE CUSTOMER). THERE WAS NO IMPACT TO PATIENT MANAGEMENT AS NO SUSPECT RESULTS WERE REPORTED OUT OF THE LABORATORY.

    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, (B)(4)| ARCHITECT I2000SR ANALYZER, (B)(4)