BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2161755 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01678
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS. IT WAS STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS AROUND 300 MG/DL AT BEDTIME. THE CUSTOMER TREATED, AND AT ABOUT MIDNIGHT, THE PARAMEDICS WERE CALLED AS THE CUSTOMER WAS UNCONSCIOUS. AFTER BEING STABILIZED, THE CUSTOMER HAD A MEAL, AND LATER EXPERIENCED LOW BLOOD GLUCOSE LEVELS, EVEN THOUGH SHE DID NOT BOLUS FOR THE MEAL. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 56 MG/DL AT THE TIME OF ADMISSION. IT WAS ALSO STATED THAT THE CUSTOMER WAS TAKING MIGRAINE MEDICATION AND SAFFRON. ADVISED THE CALLER THAT A USB CABLE WOULD BE SENT TO HER SO THAT THE INSULIN PUMP COULD BE UPLOADED TO CARELINK. ADVISED TO CALL BACK ONCE THE CABLE IS RECEIVED. 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 32 YR Hospitalization