BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2914567 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-90271
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED MOTOR ERROR DURING BASAL DELIVERY. TROUBLESHOOTING WAS PERFORMED. ASSISTED THE CALLER TO RUN THE SELF TEST AND PASSED. THE CALLER STATED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 474MG/DL. THE CALLER STATED THAT THE CUSTOMER WAS IN A VEHICLE ACCIDENT POSSIBLE DUE HIS LOW BLOOD GLUCOSE, AND THE INSULIN PUMP WAS ALARMING MOTOR ERROR WHEN HE WAS BROUGHT IN THE HOSPITAL. THE CALLER STATED THE INSULIN PUMP WAS DOWNLOADED AND FOUND THAT HE GAVE HIMSELF 40.0 UNITS OF INSULIN. IT WAS STATED THAT THE CAR ACCIDENT OCCURRED ON (B)(6) 2012, BUT THE CUSTOMER WAS FOUND THE NEXT DAY AS THE CAR WHEN DOWN THIRTY FOOT RAVINE. THE CALLER STATED THAT THE CUSTOMER IS PARALYZED FROM THE WAIST DOWN AS A RESULT OF THE ACCIDENT. REVIEWED THE ALARM HISTORY AND FOUND MOTOR ERRORS, LOW RESERVOIR, AND LOW BATTERY ALARM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20333 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization