BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDLAB 1265

    MDR report key: 3001527 · Received March 6, 2013

    Report

    Report Number
    1217157-2013-00027
    Event Type
    Other
    Date Received
    March 6, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 8, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, MFG LTD
    Product Code
    CGX
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THESE DISCORDANT N-BILIRUBIN RESULTS IS UNK.

    Description of Event or Problem · 1

    N-BILIRUBIN RESULTS ARE NOT CORRELATING BETWEEN THE RAPIDLAB 1265 AND ANOTHER METHOD. QUALITY CONTROL CORRELATIONS PERFORMED ON THE SYSTEM PREVIOUSLY WERE SATISFACTORY. THERE WAS NO IMPACT TO PT CARE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95704 RAPIDLAB 1265 RAPIDLAB 1265 CGX SIEMENS HEALTHCARE DIAGNOSTICS, MFG LTD

    Patients

    Seq Age Sex Outcome Treatment
    1