BEUDAMED
    FDA Adverse Event Summary report: N

    RAPIDLAB 1265

    MDR report key: 4170078 · Received October 14, 2014

    Report

    Report Number
    1217157-2014-00156
    Date Received
    October 14, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 21, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OPERATOR SHOULD NOT HAVE RUN PATIENT SAMPLES WHEN AUTOMATIC QUALITY CONTROL (AQC) WAS TURNED OFF ON THE INSTRUMENT. CUSTOMER INDICATED THAT INSTRUMENT WAS IN RESTRICTED MODE BUT THEY FOUND OUT THAT THERE WAS ONE OTHER PERSON WHO HAD ACCESS THAT SHOULDN'T HAVE. THEY REMOVED THAT OPERATOR'S NAME. THE EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT 6 PATIENT SAMPLES WERE RUN WHEN AUTOMATIC QUALITY CONTROL (AQC) WAS TURNED OFF ON THE INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649211 RAPIDLAB 1265 RL 1265 CHL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1