BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2170669 · Received July 11, 2011

    Report

    Report Number
    2032227-2011-01692
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 350 MG/DL. THE CUSTOMER HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR (B)(6). TROUBLESHOOTING WAS PERFORMED, AND THE DAILY TOTALS DID NOT MATCH WITH THE BASAL RATE AND BOLUS DELIVERY TOTALS. FOUND THAT THE CUSTOMER DOESN'T ALWAYS ENTER A BLOOD GLUCOSE READING WHEN USING THE BOLUS WIZARD FEATURE. ALSO FOUND THAT THE CUSTOMER USES THE DUAL/SQUARE WAVE BOLUS TO TREAT FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS ADVISED ON BOTH OF THESE ISSUES. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED DUE TO THE HISTORY ANOMALY. 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-522LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization