BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3062047 · Received April 16, 2013

    Report

    Report Number
    2032227-2013-01412
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    December 30, 2012
    Report Date
    March 27, 2013
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED WITH HIGH BLOOD GLUCOSE LEVELS BETWEEN 640 AND 680 MG/DL. THE CUSTOMER STATED THAT SHE HAS NOT BEEN USING THE INSULIN PUMP SINCE THE INCIDENT, AND HER DOCTOR REQUESTED A REPLACEMENT. THE CUSTOMER HAD GONE TO THE EMERGENCY ROOM BECAUSE SHE THOUGHT SHE WAS HAVING A HEART ATTACK, BUT ONCE SHE WAS CHECKED, SHE WAS TOLD THAT SHE WAS FEELING LIKE THAT DUE TO THE HIGH BLOOD GLUCOSE LEVELS. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163914 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization