BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3211977 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-95489
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THE DEVICE HAD A CRACKED DISPLAY WINDOW CORNER. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 50MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE DAUGHTER STATED THAT SHE FOUND HER MOTHER UNCONSCIOUS IN THE KITCHEN. SHE WOKE HER UP AND HER LOW BLOOD GLUCOSE WAS LOW. THE CALLER GAVE HER JUICE AND OATMEAL, BUT HER GLUCOSE LEVEL CONTINUED BEING LOW AND THE PARAMEDICS WERE CALLED. THE CALLER STATED THAT THEY BELIEVE THE INSULIN PUMP OVER DELIVERED INSULIN. REVIEWED THE PROGRAMMING, AND THE RESERVOIR WAS SHOWING MORE INSULIN THAT WHAT WAS SHOWING ON THE STATUS SCREEN. THE DAUGHTER DID NOT FEEL COMFORTABLE AND REQUESTED A REPLACEMENT. DURING THE CALL, IT WAS MENTIONED THAT THE CUSTOMER IS REUSING THE SUPPLIES AS SHE IS OUT OF SUPPLIES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308571 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization