BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3192664 · Received June 27, 2013

    Report

    Report Number
    2032227-2013-02587
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE INSULIN PUMP HAD A BUTTON ERROR ALARM DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP GAVE A BUTTON ERROR ALARM LAST NIGHT, AND SHE COULD NOT CLEAR THE ALARM. THE CUSTOMER STATED THAT SHE DID NOT PRESS ANY BUTTON FOR GREATER THAN THREE MINUTES. THE CUSTOMER ALSO STATED THAT SHE CALLED THE PARAMEDICS THIS MORNING DUE TO A LOW BLOOD GLUCOSE OF 23 MG/DL. THE CUSTOMER STATED THAT SHE HAD GIVEN HERSELF A MANUAL INJECTION DUE THE INSULIN PUMP BREAKING DOWN, AND IT CAUSED AN INSULIN REACTION. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292622 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention