BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INSULIN (IRI) ASSAY

    MDR report key: 5910301 · Received August 29, 2016

    Report

    Report Number
    1219913-2016-00153
    Event Type
    Malfunction
    Date Received
    August 29, 2016
    Date of Event
    August 8, 2016
    Report Date
    August 29, 2016
    Manufacturer
    KYOWA MEDEX CO., LTD. (JAPAN) FOR:
    Product Code
    CFP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REAGENTS WERE CHECKED BY THE CUSTOMER. THERE WERE NO VISIBLE CLUMPS. THE QUALITY CONTROL (QC) AND THE CALIBRATIONS WERE ACCEPTABLE. THE FIELD SERVICE ENGINEER (FSE) VERIFIED THE HARDWARE PERFORMANCE AND FOUND ALL DATA SATISFACTORY. THE FIELD APPLICATION SPECIALIST (FAS) ALSO PERFORMED OTHER PRECISION CHECKS AND SAMPLE CORRELATIONS FOR THE INSULIN (IRI) ASSAY. ALL THE DATA WAS SATISFACTORY. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP INSULIN (IRI) RESULT IS UNKNOWN. PRE- ANALYTICAL FACTORS MAY BE THE POSSIBLE CAUSE OF THE DISCORDANT RESULT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES ON THE INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS."

    Description of Event or Problem · 1

    A FALSELY ELEVATED ADVIA CENTAUR XP INSULIN (IRI) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS ELEVATED. THE PHYSICIAN SENT THE PATIENT SAMPLE TO ANOTHER LABORATORY ((B)(6) LAB) TO BE TESTED ON AN ALTERNATE PLATFORM. THE RESULT WAS LOWER. THE SAME SAMPLE WAS TESTED AT ANOTHER LOCATION ((B)(6)) ON THE ADVIA CENTAUR XP AND THE RESULT WAS SIMILAR TO THE ALTERNATE PLATFORM. THE SAMPLE WAS THEN TESTED AT THE CUSTOMER SITE ON THE ADVIA CENTAUR XP AND THE RESULT WAS SIMILAR TO THE ALTERNATE PLATFORM. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE INSULIN (IRI) DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564361 ADVIA CENTAUR XP INSULIN (IRI) ASSAY INSULIN IMMUNOASSAY CFP KYOWA MEDEX CO., LTD. (JAPAN) FOR: N/A 164

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR