BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190357 · Received July 28, 2011

    Report

    Report Number
    2032227-2011-01828
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 LOW BLOOD GLUCOSE READING OF 21 MG/DL. THE CUSTOMER HAD NO IDEA WHY HIS BLOOD GLUCOSE LEVELS DROPPED SO LOW. PRIOR TO THE HOSPITALIZATION, THE CUSTOMER WAS ON HIS DRIVEWAY, AND TRIPPED OVER A BOX, DAMAGING THE INSULIN PUMP. THE CUSTOMER STATED THAT THE INSULIN PUMP HAS OT WORKED SINCE HE FELL. THE CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 480 MG/DL. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. 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-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization