BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3092904 · Received May 3, 2013

    Report

    Report Number
    2032227-2013-01610
    Event Type
    Malfunction
    Date Received
    May 3, 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
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A LOOSE DRIVE SUPPORT DISK. UNABLE TO VERIFY ANY ALARMS DUE TO THE PRIME ANOMALY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE INSULIN PUMP GAVE AN ALARM DURING NORMAL USE. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. GAVE THE CUSTOMER HER OUT OF WARRANTY OPTIONS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195316 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR