BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3923694 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-86595
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 ABOUT HIGH BLOOD GLUCOSE LEVELS. SHE HAS BEEN HAVING HIGHS IN THE RANGE OF 270 MG/DL, AND HER CURRENT BLOOD GLUCOSE LEVEL IS 276 MG/DL. SHE IS TREATING WITH THE INSULIN PUMP. CUSTOMER ALSO MENTIONED A HOSPITALIZATION FOR LOW BLOOD GLUCOSE ON (B)(6) 2014. SHE STATED THAT SHE IS NOT SURE IF THE INSULIN PUMP IS OVER DELIVERING OR NOT. CUSTOMER STATED SHE IS NOT SURE OF THE CAUSE OF HER LOW BLOOD GLUCOSE LEVELS. HER BLOOD GLUCOSE LEVEL AT THE TIME OF ADMISSION WAS 50 MG/DL. NO OTHER DETAILS ABOUT THE HOSPITALIZATION WERE PROVIDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399630 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 67 YR Hospitalization