BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500

    MDR report key: 3722334 · Received April 2, 2014

    Report

    Report Number
    1217157-2014-00048
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KHP
    PMA / PMN Number
    K113216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN INCORRECT CORRELATION FACTOR WAS ENTERED INTO THE PH FIELD OF THE INSTRUMENT. CUSTOMER ALSO REPORTED THAT THEY HAVE SEEN PATIENT SAMPLES WITH LOW PH VALUES DUE TO AN INCORRECT FACTOR ENTERED INTO THE OFFSET FIELD (-0.3). THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198933 RAPIDPOINT 500 RP 500 KHP SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1