BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5520406 · Received March 23, 2016

    Report

    Report Number
    3004209178-2016-99943
    Event Type
    Injury
    Date Received
    March 23, 2016
    Date of Event
    August 17, 2014
    Report Date
    August 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    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

    THE CUSTOMER REPORTED VIA PHONE CALL, THE CUSTOMER HAD RECENTLY PROGRAMED HEW NEW INSULIN PUMP BUT HAS BEEN HAVING LOW BLOOD GLUCOSE LEVELS. CUSTOMER WASN'T SURE IF SHE PROGRAMED THE DEVICE CORRECTLY. THE CUSTOMER REPORTED LOW BLOOD GLUCOSE OF 48 MG/DL, TREATING WITH HAVING DINNER. TESTED AGAIN AND HER BLOOD GLUCOSE WAS 161 MG/DL. TROUBLESHOOTING WAS PERFORMED ON THE INSULIN PUMP AND NO ANOMALIES WERE NOTED. THE DEVICE WAS PROGRAMMED CORRECTLY AND THE CUSTOMER WAS ADVISED TO SPEAK TO HER DOCTOR IN REGARDS TO LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER IS NOT RETURNING THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177102 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other