BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4151657 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-34700
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND RESERVOIR TUBE LIP. UNIT RECEIVED WITH BROKEN BELT CLIP SLOT. UNIT RECEIVED WITH MINOR SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BUTTON ERROR ALARM. SHE ALSO STATED SHE HAD REPLACED HER BATTERY BUT THE PROBLEM PERSISTS. THE CUSTOMER'S BLOOD GLUCOSE WAS 166 MG/DL. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633550 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR