BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2993612 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-91645
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 25, 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

    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 WAS HOSPITALIZED OVER THE WEEKEND DUE TO HIGH BLOOD GLUCOSE OF 849MG/DL. THE MOTHER STATED THAT THE INSULIN PUMP TURNED OFF, AND IT CAUSED HER BLOOD GLUCOSE TO RISE. TROUBLESHOOTING COULD NOT BE PERFORMED AS THE CALLER DID NOT HAVE A BATTERY. ADVISED THE MOTHER TO CALL BACK WHEN SHE HAS THE BATTERY TO CONTINUE TESTING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96964 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization