BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 1000 IGF-1

    MDR report key: 5468503 · Received February 29, 2016

    Report

    Report Number
    2432235-2016-00109
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Date of Event
    November 24, 2015
    Report Date
    February 4, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) SPECIALIST. A SIEMENS DESIGNATED COMPLAINT HANDLING UNIT (DCU) DETERMINED THAT IGF-1 REAGENT LOTS ARE KITTED AND VALIDATED WITH SPECIFIC PRE-TREATMENT DILUENT LOTS. IGF-1 REAGENT LOT 412 WAS KITTED AND VALIDATED WITH PRE-TREATMENT DILUENT LOT 057. NO OTHER LOT OF PRE-TREATMENT DILUENTS CAN BE USED WITH IGF-1 REAGENT LOT 412. THE CAUSE OF INCORRECT USAGE OF PRE-TREATMENT DILUENT LOT 055 WITH IGF-1 REAGENT LOT 412 IS DUE TO OFF-LABEL USE.

    Description of Event or Problem · 1

    THE OPERATOR OF AN IMMULITE 1000 INSTRUMENT REPORTED THAT WHILE USING INSULIN-LIKE GROWTH FACTOR 1 (IGF-1) REAGENT LOT 412 IN COMBINATION WITH PRE-TREATMENT DILUENT LOT 055, IT TAKES A LONG TIME BEFORE THE IGF-1 IS RELEASED FROM BINDING PROTEIN 3 (BP3). THE CUSTOMER STATED THAT IT TAKES APPROXIMATELY 2 HOURS OF PRE-INCUBATION BEFORE A STABLE IGF-1 RESULT IS OBTAINED. THE CUSTOMER ALSO STATED THAT WHILE RUNNING TESTS WITH PRE-TREATMENT DILUENT LOT 057 DID NOT SHOW THIS PHENOMENON. THE CUSTOMER WAS NOT REPORTING ANY PATIENT RESULTS WITH REAGENT LOT 412 AND PRE-TREATMENT DILUENT LOT 055. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE USE OF INCORRECT COMBINATION OF PRE-TREATMENT DILUENT LOT 055 WITH IGF-1 REAGENT LOT 412.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123267 IMMULITE 1000 IGF-1 IMMULITE 1000 IGF-1 CFL SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 1000 IGF-1 412

    Patients

    Seq Age Sex Outcome Treatment
    1