BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3260452 · Received August 1, 2013

    Report

    Report Number
    3004209178-2013-96372
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    June 29, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    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 TO REPORT A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. THE CURRENT BLOOD GLUCOSE READING IS 104 MG/DL. CUSTOMER EXPERIENCED SEVERE CRAMPING AND DEHYDRATION. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 458 MG/DL. CUSTOMER STATED THAT SHE HAD BENT CANNULAS. CUSTOMER STATED THAT HIGH BLOOD GLUCOSE MAY BE RELATED TO SCAR TISSUE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359332 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization