BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3812923 · Received May 15, 2014

    Report

    Report Number
    2032227-2014-02383
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 REPORTED THAT SHE WAS UNABLE TO CONTROL HER BLOOD GLUCOSE AND SHE WAS HOSPITALIZED DUE TO HIGH AND LOW BLOOD GLUCOSE. THE HIGH BLOOD GLUCOSE READING WAS OVER 400 MG/DL AND THE LOW WAS 30 MG/DL. CUSTOMER STATED THAT HER INSULIN PUMP WAS SHUTTING OFF AND IT WAS NOT GIVING HER THE RIGHT AMOUNT OF INSULIN. CUSTOMER STATED THAT WAS THROWING UP AND ASPIRATED SOME OF THE VOMIT WHICH LED TO HOSPITALIZATION. CUSTOMER STATED THAT AT THE HOSPITAL SHE HAD PNEUMONIA, RESPIRATORY FAILURE, HEART ATTACK, STROKE AND CONGESTIVE HEART FAILURE. CUSTOMER STATED THAT SHE WAS ALSO HOSPITALIZED IN (B)(6) OF 2013 FOR HIGH BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291157 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization