BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3110035 · Received May 13, 2013

    Report

    Report Number
    2032227-2013-01919
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION. NO UNEXPECTED LOW BATTERY ALARMS WERE NOTED. THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A LOOSE/FLUSH MOTOR SUPPORT DISK. THE INSULIN PUMP HAD A SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT LOW BATTERY LIFE. TROUBLESHOOTING DID NOT SOLVE THE ISSUE. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. THE REPORTED BLOOD GLUCOSE READING WAS 132 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211529 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR