BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3222915 · Received July 12, 2013

    Report

    Report Number
    2032227-2013-02845
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 15, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    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

    CUSTOMER'S SPOUSE CALLED TO REPORT A HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. CALLER STATED THAT CUSTOMER RECEIVED THE NOTIFICATION LETTER REGARDING THE VENT BLOCKAGE. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 192 MG/DL. PARAMEDICS WERE CALLED TO TREAT A LOW BLOOD GLUCOSE READING OF 42 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321612 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization