BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3141083 · Received June 3, 2013

    Report

    Report Number
    2032227-2013-02220
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 14, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE DRIVE SUPPORT CAP WAS INSPECTED AND NO ANOMALY NOTED. THE INSULIN PUMP HAD CRACKED CASE AROUND THE RESERVOIR TUBE WINDOW AND BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 675MG/DL. THE CUSTOMER STATED THAT SHE WAS NOT GETTING INSULIN DUE TO THE BENT CANNULA. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. THE ALARM HISTORY SHOWS A LOW RESERVOIR AND LOW BATTERY ALARM. THE CALLER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED AND STICKING OUT. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243003 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization