BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4223080 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-47408
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED WITH OPERATING CURRENTS WITHIN SPEC. NO UNEXPECTED WEAK BATTERY OR FAILED BATTERY TEST ALARMS NOTED. UNIT ALARMED A21 AFTER BATTERY INSTALLATION DUE TO BROKEN SOLDER JOINT AT C13 I/B. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND BATTERY TUBE THREADS. UNIT RECEIVED WITH SCRATCHED DISPLAY WINDOW. NO UNEXPECTED A17 ALARMS NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP RETURNED MULTIPLE WEAK BATTERY, FAILED BATTERY, AND ADDITIONAL ERROR ALARMS. BLOOD GLUCOSE LEVEL WAS 260 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706175 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR