BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1994146 · Received February 16, 2011

    Report

    Report Number
    2032227-2011-00456
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 27, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING A LOW BLOOD GLUCOSE READING OF 44 MG/DL. THE CUSTOMER REVIEWED THE BOLUS HISTORY, AND FOUND A BOLUS OF 2.8 UNITS THAT HE DID NOT RECALL PROGRAMMING. THE CUSTOMER WENT OFF THE INSULIN PUMP AT THAT TIME, AND EXPERIENCED HIGH BLOOD GLUCOSE LEVELS THE NEXT DAY. THE CUSTOMER WENT TO THE EMERGENCY ROOM FOR TREATMENT AND A BACK UP PLAN. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED DUE TO THE BOLUS THAT HE FELT HE DID NOT PROGRAM. 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 LZG MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR