BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 1781417 · Received August 3, 2010

    Report

    Report Number
    1628664-2010-00279
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 5, 2010
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). A PRODUCT DEFICIENCY HAS BEEN IDENTIFIED. WITH A UNIQUE COMBINATION OF INSTRUMENT AND REAGENT CONDITIONS THERE IS A POTENTIAL FOR SAMPLE CARRYOVER WHICH CAN RESULT IN FALSELY ELEVATED B-HCG CONCENTRATIONS ON THE ARCHITECT I1000SR SYSTEM. NEGATIVE SAMPLES HAVE RETURNED BOTH POSITIVE AND GREY ZONE B-HCG RESULTS WHEN A HIGH CONCENTRATION B-HCG SAMPLE IS ASSESSED PRIOR TO THE NEGATIVE SAMPLE WITH ARCHITECT TOTAL B-HCG (LIST NUMBER 7K78/6C21) ON AN I1000SR INSTRUMENT WHICH ALSO UTILIZES THE ARCHITECT RUBELLA IGG (LIST NUMBER 6C17) ASSAY. FURTHER INVESTIGATION OF THIS QUALITY ISSUE WILL BE CONDUCTED. AN INVESTIGATION IS IN PROCESS

    Additional Manufacturer Narrative · 1

    (B)(4). MFR # 3005094123-2011-00582 HAS BEEN SUBMITTED TO ADDRESS THIS ERROR.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT I1000SR ANALYZER HAS GENERATED FALSE POSITIVE B-HCG RESULTS FOR 2 PATIENT SAMPLES. FOR PATIENT #1, THE INITIAL RESULTS WAS POSITIVE AT 16.0 MIU/ML, THE RETEST RESULT WAS NEGATIVE AT < 2.0 MIU/ML. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TOTAL B-HCG AUTOMATED IMMUNOASSAY ANALYZER DHA A.I.D.D LONGFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 B-HCG REAGENT: LIST 7K78-25, LOT UNK| B-HCG REAGENT: LIST 7K78-25, LOT UNK