BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3951343 · Received July 22, 2014

    Report

    Report Number
    2032227-2014-04735
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    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 WITH HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. THE PATIENT WAS GIVEN AN INJECTION BY HER DOCTOR AND SENT TO THE EMERGENCY ROOM. HER BLOOD GLUCOSE LEVEL WAS 600 MG/DL. IT WAS FURTHER REPORTED THAT THE DIABETIC KETOACIDOSIS WAS DUE TO THE CUSTOMER'S INSULIN PUMP BEING OFF. THE INSULIN PUMP WAS REMOVED FROM PATIENT IN THE EMERGENCY ROOM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428926 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization