BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2121448 · Received June 7, 2011

    Report

    Report Number
    2032227-2011-01379
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 21, 2011
    Report Date
    May 21, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 CALLED TO REPORT THAT SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR THE PAST DAY. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 407 MG/DL. THE CUSTOMER WAS ALSO THROWING UP, AND FELT HOT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THERE WAS NO TUBING CLAMP FOR THE HIGH PRESSURE TEST. THE CUSTOMER TREATED HER BLOOD GLUCOSE LEVELS AT THE TIME OF THE CALL, BUT HER BLOOD GLUCOSE REMAINED ELEVATED. THE CUSTOMER WAS ADVISED TO SEEK MEDICAL ATTENTION, AND SHE STATED THAT SHE WOULD BE GOING TO THE EMERGENCY ROOM. 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 MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization