BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2020471 · Received February 16, 2011

    Report

    Report Number
    3004209178-2011-80429
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 THE INSULIN PUMP WAS NOT GIVING HIM THE CORRECT BOLUS AMOUNT. THE CUSTOMER STATED HAVING HIGH BLOOD GLUCOSE FOR A FEW DAYS. REQUESTED CUSTOMER TO RUN A FIXED PRIME TEST, BUT THE CUSTOMER DECLINED. THE CUSTOMER STATED THAT HE BOLUSES CORRECTLY, BUT HIS GLUCOSE LEVEL DOES NOT DROP. EXPLAINED THE CUSTOMER THAT HIS BASAL RATES MAY NEED TO BE ADJUSTED. ADVISED THE CUSTOMER TO CONTACT HIS DOCTOR ABOUT INCREASING THE BASAL RATES AS WELL TO ACCOMMODATE THE TIME THAT HE IS RUNNING HIGH WITHOUT EATING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR