BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2111817 · Received May 26, 2011

    Report

    Report Number
    3004209178-2011-81617
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND DEHYDRATION, WITH BLOOD GLUCOSE OVER 500 MG/DL. THE CUSTOMER'S FATHER STATED THAT PRIOR TO THE EVENT, THE PHYSICIAN HAD CHANGED THE CUSTOMER'S BASAL RATES FROM FOUR DIFFERENT RATES TO ONE. THE CUSTOMER'S FATHER ALSO STATED THAT THE CUSTOMER USES A MIO INFUSION SET THE DAY OF THE EVENT. PROGRAMMING WAS CORRECT. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE FIXED PRIME AND HIGH PRESSURE TESTS. NOTHING FURTHER WAS REPORTED.

    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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization UNOMEDICAL MIO INSULIN INFUSION SET: MODEL MMT-941| LOT 3700041.