BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2142410 · Received June 21, 2011

    Report

    Report Number
    2032227-2011-01546
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 12, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 SHE WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 600 MG/DL. THE CUSTOMER WAS AT WORK PRIOR TO THE EVENT, AND HAD TO CALL THE PARAMEDICS. THE CUSTOMER WAS TIRED, AND HER LEGS WERE HURTING. DURING THE CALL, THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS, AND STATED THAT SHE JUST ARRIVED AT THE HOSP WITH HER DAD. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 533 MG/DL, AND SHE HAD KETONES. THE CUSTOMER WAS NOT COMFORTABLE WITH THE INSULIN PUMP, AND REQUESTED A REPLACEMENT. THE CUSTOMER DECLINED TROUBLESHOOTING. 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-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization