BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3081259 · Received April 26, 2013

    Report

    Report Number
    2032227-2013-01542
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, EXHAUSTION AND FLU-LIKE SYMPTOMS. IT WAS REPORTED THAT THE BLOOD GLUCOSE READING WAS TOO HIGH TO REGISTER ON THE GLUCOMETER. IT WAS REPORTED THAT THE CUSTOMER MAY NOT HAVE BEEN CHECKING HER BLOOD GLUCOSE LEVELS REGULARLY. THE CALLER STATED THAT THE CUSTOMER HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR ABOUT TWO WEEKS, AND HAD JUST SEEN HER DOCTOR THREE WEEKS EARLIER. THE CALLER ASKED ABOUT THE GLUCOSE METER COMMUNICATION WITH THE INSULIN PUMP, AND DECLINED FURTHER TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182870 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization