BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 2050918 · Received April 12, 2011

    Report

    Report Number
    3002809144-2011-00187
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICE: ARCHITECT I2000SR ANALYZER, LIST # 3M74-02, SERIAL # (B)(4). RESULTS: CROSS CONTAMINATION WAS IDENTIFIED AS A POTENTIAL CAUSE. (B)(4). AN ADVERSE TREND IN US CUSTOMER COMPLAINTS FOR ARCHITECT HAVAB-IGM ASSAY (B)(4) 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)(4) 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/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 (B)(6) SAMPLES.

    Description of Event or Problem · 1

    THE CUSTOMER STATED FIVE PATIENT SAMPLES GENERATED GRAY ZONE TO FALSE LOW REACTIVE RESULTS WHEN ARCHITECT HAVAB-M REAGENT LOT 93794HN00 WAS IN USE. THE CUSTOMER STATED THEY USUALLY DO NOT OBSERVE GRAY ZONE OR REACTIVE RESULTS. THE CUSTOMER FURTHER STATED THE QUALITY CONTROLS WERE ALSO RUNNING HIGHER BUT WERE WITHIN ACCEPTABLE LIMITS. THE CUSTOMER RETESTED THE SAMPLES WITH A DIFFERENT LOT OF REAGENT AND ALL REPEAT RESULTS WERE NON-REACTIVE. THE CUSTOMER PROVIDED AN EXAMPLE OF THE INITIAL GRAY ZONE RESULT AND THE REPEAT RESULT AS FOLLOWS: (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT AS THE GRAY ZONE RESULT WAS NOT 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, LIST # 3M74-02| ARCHITECT I2000SR ANALYZER, LIST # 3M74-02