BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3833501 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-85023
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 9, 2014
    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

    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

    CUSTOMER CALLED IN TO REPORT HOSPITALIZATION BECAUSE OF A HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 470 MG/DL. CUSTOMER UNABLE TO READ THE DISPLAY. CUSTOMER DIAGNOSED WITH HIGH BLOOD GLUCOSE AND LOW SODIUM. THE INSULIN PUMP HAS MISSING SEGMENTS IN THE DISPLAY. ADVISED CUSTOMER TO REVERT TO BACK UP DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310038 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization