BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2842627 · Received November 21, 2012

    Report

    Report Number
    2032227-2012-07790
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    November 3, 2012
    Report Date
    November 4, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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.

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM DURING THE BASIC OCCLUSION TEST DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORM THE OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST DUE TO MOTOR ERROR ALARM. THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS. NO UNEXPECTED BAD BATTERY ALARM NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DKA. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS 589 MG/DL. CALLER STATED THAT THE CUSTOMER HAD NAUSEA END WAS VOMITING PRIOR TO HOSPITALIZATION. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE HIGH-PRESSURE TEST TWICE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-722LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization