BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2842265 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-90872
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED UNEXPLAINED HIGH BLOOD GLUCOSE OF 600MG/DL, AND HIS BLOOD GLUCOSE WAS TREATED WITH THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. THE MOTHER WAS NOT SURE IF THE BASAL RATE WAS CORRECT, BUT THE BOLUS WIZARD SETTING WAS CORRECT. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. ADVISED THE MOTHER TO CALL BACK WHEN THE TUBING CLAMP ARRIVES TO CONTINUE TESTING. THE MOTHER CALLED BACK AND STATED THAT HER SON'S BLOOD GLUCOSE WAS INCREASING AND SHE IS DRIVING HIM TO THE EMERGENCY ROOM. DURING THE CALL, THE MOTHER ALSO MENTIONED THAT THE CUSTOMER WAS HOSPITALIZED ON (B)(6), 2012 DUE TO HIGH BLOOD GLUCOSE OF 800MG/DL. TWO DAYS LATER, THE MOTHER CALLED BACK AND REQUESTED ASSISTANCE WITH PROGRAMMING A BOLUS FOR A CORRECTION AND TO SET A TEMPORARY BASAL FOR TWENTY FOUR HOURS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization