BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090136 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81365
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 THAT SHE WAS TREATED BY PARAMEDICS FOR LOW BLOOD GLUCOSE OF 45MG/DL. THE CUSTOMER STATED THAT SHE DRANK JUICE. THE CUSTOMER DECLINED TO TAKE GLUCAGON AS WELL TO GO TO THE HOSPITAL. THE CUSTOMER STATED THAT HER GLUCOSE CAME BACK UP TO 88MG/DL AND THEN SHE HAD A MEAL. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING ON THE INSULIN AND IT APPEARS TO BE FINE. THE AMOUNT OF INSULIN IN THE RESERVOIR MATCHES TO THE UNITS LEFT IN THE STATUS SCREEN. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization