BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4151661 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-34702
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE CUSTOMER STATED HE WAS HAVING SYMPTOMS OF DIABETES KETOACIDOSIS, LEADING HIM TO BE ADMITTED TO THE HOSPITAL. DATE OF HOSPITALIZATION WAS (B)(6) 2014. BLOOD GLUCOSE AT THE TIME OF HOSPITALIZATION WAS 480 MG/DL. THE CUSTOMER STATED HE WAS FEELING NAUSEOUS AND FATIGUED PRIOR TO BEING HOSPITALIZED. THE CUSTOMER STATED HE WAS NOT IN A VEHICULAR ACCIDENT. HE WAS STILL IN THE HOSPITAL FOR DIABETES KETOACIDOSIS. THE CUSTOMER ALSO REPORTED A BUTTON ERROR ALARM. THE CUSTOMER STATED HIS INSULIN PUMP MAY HAVE BEEN EXPOSED TO MOISTURE. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633372 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization