BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC MINIMED PARADIGM INSULIN PUMP

    MDR report key: 1694876 · Received May 11, 2010

    Report

    Report Number
    MW5015980
    Event Type
    Other
    Date Received
    May 11, 2010
    Date of Event
    April 25, 2010
    Report Date
    May 11, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    LZG
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN ACCORDANCE WITH 21 CFR 803.22 (B)(2), WE ARE NOTIFYING YOU THAT ON (B) (6) 2010, A CUSTOMER CONTACTED ROCHE DIAGNOSTICS AND REPORTED A HYPOGLYCEMIC EVENT THAT OCCURRED ON (B) (6) 2010. AT 11:30 A.M., THE CUSTOMER TOOK A BLOOD GLUCOSE READING OF 451 MG/DL AND ADJUSTED THE MEDTRONIC MINIMED PARADIGM INSULIN PUMP TO TAKE 10 UNITS OF HUMALOG. AN UNSPECIFIED TIME LATER, THE CUSTOMER WAS FOUND BY HIS WIFE UNRESPONSIVE AND APPARENTLY HAVING A SEIZURE; SHE CALLED EMTS. AT 1:00 AM, EMT SYSTEM RESULT WAS 22 MG/DL. EMTS TREATED THE CUSTOMER, TRANSPORTED HIM TO A HOSPITAL FOR FURTHER TREATMENT. THE MEDTRONIC MINIMED PARADIGM INSULIN PUMP MENTIONED IN THIS EVENT IS NOT MFG OR IMPORTED BY OUR FIRM. (B) (6)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM INSULIN PUMP NONE LZG MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1