BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDLAB 1265

    MDR report key: 3601613 · Received January 13, 2014

    Report

    Report Number
    1217157-2013-00258
    Event Type
    Other
    Date Received
    January 13, 2014
    Date of Event
    December 17, 2013
    Report Date
    December 17, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    CGX
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT IONIZED CALCIUM (CA++) RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 9 DISCORDANT IONIZED CALCIUM (CA++) RESULTS ON THE INSTRUMENT. CUSTOMER ONLY PROVIDED DATA ON TWO SAMPLES FROM THE SAME PATIENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23467 RAPIDLAB 1265 RL 1265 CGX SIEMENS HEALTHCARE DIAGNOSTICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1