BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 2072935 · Received April 29, 2011

    Report

    Report Number
    3002809144-2011-00227
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL IDENTIFIER(S): =(B)(4). CONCOMITANT MEDICAL DEVICE: ARCHITECT I2000SR ANALYZER, LIST # 3M74-02, SERIAL # (B)(4). EVALUATION RESULTS: CROSS CONTAMINATION WAS IDENTIFIED AS A POTENTIAL CAUSE. CONCLUSION: (B)(4) MANUFACTURING PROCESS. AN ADVERSE TREND IN US CUSTOMER COMPLAINTS FOR ARCHITECT HAVAB-IGM ASSAY (LIST NUMBER 6L21) REGARDING HIGHER THAN USUAL GRAYZONE/(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 NEGATIVE SAMPLES LEAVING THE ASSAY PRONE FOR FALSE GRAYZONE/(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.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED ABBOTT REGARDING INCREASED INCIDENTS OF ARCHITECT HAVAB-M GRAY ZONE AND (B)(6) PATIENT RESULTS WHEN REAGENT LOT 93794HN00 WAS IN USE SINCE 3/20/11. AFTER TROUBLESHOOTING THE ISSUE WITH THE CUSTOMER, A REPLACEMENT LOT OF HAVAB-M REAGENT WAS SENT WHICH THE CUSTOMER STATED WAS RUNNING BETTER THAN THE PREVIOUS LOT. THE CUSTOMER PROVIDED AN EXAMPLE OF REACTIVE HAVAB-M RESULTS AS FOLLOWS: SAMPLE ID# (B)(6) INITIAL RESULT: (B)(6), RESPECTIVELY. NO ADDITIONAL TESTING WAS PERFORMED ON THIS SAMPLE TO CONFIRM THE INITIAL (B)(6) RESULTS. THERE WAS NO KNOWN IMPACT TO PATIENT MANAGEMENT REPORTED BY THE CUSTOMER.

    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# 3M74-023M| ARCHITECT I2000SR ANALYZER, LIST# 3M74-023M