BEUDAMED
    FDA Adverse Event Summary report: N

    RAPIDPOINT 500

    MDR report key: 5068858 · Received September 10, 2015

    Report

    Report Number
    1217157-2015-00131
    Date Received
    September 10, 2015
    Date of Event
    August 12, 2015
    Report Date
    October 5, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KHP
    PMA / PMN Number
    K113216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS IS IN PROCESS OF INVESTIGATING THIS EVENT. THE CAUSE FOR THE EVENT IS UNKNOWN AT THIS MOMENT.

    Additional Manufacturer Narrative · 1

    SIEMENS SOFTWARE ENGINEERING TEAM REVIEWED THE COMPLAINT AND WAS UNABLE TO REPRODUCE THE EVENT. CUSTOMER HAS NOT INDICATED ANY ADDITIONAL OCCURRENCES. THERE ALSO HAVE NOT BEEN ANY PREVIOUS DOCUMENTED OCCURRENCES OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ANALYZER POPULATED OPERATOR ID ON THE PATIENT ID FIELD ON THE DEMOGRAPHIC SCREEN WHILE RUNNING BLOOD SAMPLES. CUSTOMER INDICATED THAT ON (B)(6) 2015; THEY WERE RUNNING BLOOD SAMPLES AFTER INSTALLING NEW MEASUREMENT CARTRIDGE AND NOTICED THAT HER OPERATOR ID ((B)(6)) POPULATED ON THE PATIENT ID FIELD BEFORE SCANNING OR TYPING ANYTHING ON THE PATIENT ID FIELD. THERE WAS NO REPORT OF SERIOUS INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600462 RAPIDPOINT 500 RP 500 KHP SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR