BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 500

    MDR report key: 3608253 · Received January 23, 2014

    Report

    Report Number
    1217157-2013-00262
    Event Type
    Other
    Date Received
    January 23, 2014
    Date of Event
    December 15, 2013
    Report Date
    December 26, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    KHP
    PMA / PMN Number
    K113216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER IS BEING INSTRUCTED TO SET UP AUTOMATIC QUALITY CONTROL (AQC) ON THE INSTRUMENT. CUSTOM SHOULD NOT HAVE RUN PT SAMPLES WHEN AQC WAS OFF ON THE INSTRUMENT. THE EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR. INSTRUMENT IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT AUTOMATIC QUALITY CONTROL (AQC) WAS NOT RUN ON THE INSTRUMENT FROM (B)(6) 2013. CUSTOMER INDICATED THAT 15 PT SAMPLES WERE RUN DURING THIS TIME FRAME. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55040 RAPIDPOINT 500 RAPIDPOINT 500 KHP SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1