BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4103429 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26299
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    June 2, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REPORTED AN EMERGENCY ROOM VISIT DUE TO LOW BLOOD GLUCOSE READINGS. CUSTOMER STATED THAT SHE FAINTED DUE TO LOW BLOOD GLUCOSE READINGS. WHEN THE CUSTOMER WOKE UP, SHE CALLED HER GRANDSON WHO CALLED THE PARAMEDICS. CUSTOMER STATED THAT SHE IS UNSURE OF EVENTS LEADING UP TO THE EMERGENCY ROOM VISIT, HOWEVER, BELIEVES THAT SHE RAN LOW DURING THE NIGHT AND WAS UNAWARE OF IT. CUSTOMER WAS KEPT IN THE HOSPITAL FOR A WEEK AND THEN TRANSFERRED TO A NURSING HOME. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584759 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization