BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 1820883 · Received August 31, 2010

    Report

    Report Number
    2623532-2010-00064
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS INT'L, LTD
    Product Code
    LOL
    PMA / PMN Number
    N/A
    Removal / Correction Number
    2623532-1/4/10-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ARCHITECT HAVAB-IGM, LIST NUMBER 6L21-25 IS CURRENTLY THE FOCUS OF A PRODUCT CORRECTION, REPORTED UNDER 2623532-1/4/10-001-C. THIS REPORT IS BEING FILED FOR THE INTERNATIONAL PRODUCT, ARCHITECT HAVAB-IGM, LIST NUMBER 6C30. THIS IS AN INITIAL REPORT. THE INVESTIGATION INTO THE CAUSE IS STILL ONGOING AND APPROPRIATE CORRECTIVE ACTIONS WILL BE IMPLEMENTED UPON INVESTIGATION COMPLETION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE ARCHITECT HAVAB-IGM NEGATIVE CONTROL WAS VERY HIGH. ADDITIONALLY, THERE WAS AN INCREASE IN GRAY ZONE PATIENT RESULTS. ARCHITECT HAVAB-IGM IS CURRENTLY THE FOCUS OF A PRODUCT CORRECTION. CURRENT INFORMATION INDICATES THAT ELEVATED GRAYZONE, REACTIVE PATIENT RESULTS, OR ELEVATED OUT OF RANGE HIGH NEGATIVE QUALITY CONTROL RESULTS FOR ARCHITECT HAVAB-IGM MAY OCCUR WHEN THE ASSAY IS RUN DIRECTLY FOLLOWING THE ARCHITECT ANTI-HBS ASSAY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    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 DIAGNOSTICS INT'L, LTD 88958HN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR, 3M74-02, SN (B)(4)| ARCH I2000SR, 3M74-02, SN (B)(4)