BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2202564 · Received August 5, 2011

    Report

    Report Number
    2032227-2011-01969
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. 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 THAT HE WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 470 MG/DL. THE CUSTOMER HAD CHANGED THE INFUSION SET THE DAY PRIOR TO THE EVENT. THE CUSTOMER STATED THAT HE GAVE HIMSELF A TOTAL OF 40 UNITS OF INSULIN, BUT HIS BLOOD GLUCOSE LEVELS REMAINED ELEVATED. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. HOWEVER, THE CUSTOMER STATED THAT HE HAD NOT PROGRAMMED ANY BOLUSES FOR TODAY, YET THE BOLUS HISTORY SHOWS THAT 25 UNITS HAVE BEEN DELIVERED BY BOLUS DELIVERY. THE CUSTOMER STATED THAT HE WOULD FEEL MORE COMFORTABLE WITH A REPLACEMENT INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization