BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INSULIN (IRI) ASSAY

    MDR report key: 2429984 · Received January 27, 2012

    Report

    Report Number
    1219913-2012-00032
    Event Type
    Malfunction
    Date Received
    January 27, 2012
    Date of Event
    September 30, 2011
    Report Date
    December 28, 2011
    Manufacturer
    KYOWA MEDEX CO., LTD. (JAPAN) FOR:
    Product Code
    CFP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE HIGH BIAS IN QUALITY CONTROL (QC) FOR THE ADVIA CENTAUR XP INSULIN (IRI) ASSAY WHEN USING LOT #85 IS UNKNOWN. BOTH SIEMENS HEALTHCARE DIAGNOSTICS AND KYOWA INVESTIGATED THE ISSUE. THE IN-HOUSE AND COMMERCIAL QC RESULTS WERE WITHIN (B)(4) AND THE (B)(4) PATIENT RESULTS WERE WITHIN (B)(4) THE DATA FOR THE QC AND PATIENTS IS WITHIN SPECIFICATIONS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A HIGH BIAS IN QUALITY CONTROL (QC) VALUES WAS OBSERVED FOR THE ADVIA CENTAUR XP INSULIN (IRI) ASSAY WHEN USING LOT #85. THE QC ISSUES WERE RESOLVED AT THE CUSTOMER SITE WITH NEW REAGENT LOT # 86. THE CUSTOMER REPEATED PREVIOUS PATIENT SAMPLES AND THE REPEATS WERE OUTSIDE OF THE LIMIT OF ACCEPTABILITY. NO RESULTS WERE REPORTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP INSULIN (IRI) ASSAY INSULIN IMMUNOASSAY CFP KYOWA MEDEX CO., LTD. (JAPAN) FOR: N/A 085

    Patients

    Seq Age Sex Outcome Treatment
    1