BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4173727 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38350
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 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

    IT IS REPORTED THAT A CUSTOMER WAS HOSPITALIZED DUE TO A STROKE THAT THE PATIENT SUFFERED. THE PATENT'S BLOOD GLUCOSE LEVEL WAS NOT RECORDED. THE CALLER WAS THE PATIENT'S HUSBAND WHO CALLED TO COMPLAIN THAT THE INSULIN PUMP THE CUSTOMER WAS USING WAS STUCK IN PRIMING STAGE. THE CUSTOMER WANTED TO EXTRACT THE SENSOR READINGS TO SUPPLY THE DOCTOR WITH READINGS. THE CALLER WAS ASSISTED WITH TROUBLE SHOOTING SUCCESSFULLY AND NEEDED NO FURTHER ASSISTANCE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655940 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