BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2112390 · Received May 26, 2011

    Report

    Report Number
    3004209178-2011-81589
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    November 16, 2010
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    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 THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE CUSTOMER STATED THAT SHE HAS NOT BEEN TREATING FOR HER OVER NIGHT HIGH BLOOD GLUCOSE LEVELS DUE TO THE EXTREME LOW BLOOD GLUCOSE LEVELS IN THE MORNING THAT THEY CAUSE. THE CUSTOMER THEN STATED THAT SHE HAD BEEN HAVING LOW BLOOD GLUCOSE LEVELS FOR THE PAST SIX MONTHS. THE CUSTOMER FURTHER STATED THAT HER DOCTOR LOWERED HER BLOOD GLUCOSE SETTINGS FOR NIGHT TIME, BUT THAT SHE LOWERED THE SETTINGS EVEN MORE TO COMPENSATE FOR THE MORNING LOW BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. 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-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization