BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4100831 · Received September 16, 2014

    Report

    Report Number
    2032227-2014-23456
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, SELF TEST, AND BASIC OCCLUSION TEST. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. OFF NO POWER ALARM FUNCTIONS PROPERLY. NO MOTOR ERROR ALARM NOTED. THE DEVICE WAS UNABLE TO BE PRIMED DURING PRIME TEST DUE TO FAULTY FORCE SENSOR RESISTOR. UNABLE TO PERFORM THE OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME/FILL ANOMALY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE LIP AND A MISSING END CAP STICKER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. THE CUSTOMER STATED THAT THE EVENT LEADING TO THE EMERGENCY ROOM VISIT WAS GASTROPARESIS, THEY WERE NOT FEELING WELL AND THE INSULIN PUMP HAD ALARMED MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS ABOVE 600 MG/DL AT THE TIME OF THE HOSPITALIZATION. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD ALARMED MOTOR ERROR DURING BOLUS DELIVERY. THE CUSTOMER DOES NOT USE THE SENSOR FEATURE. THEY WERE UNABLE TO REWIND THE DEVICE. THE CUSTOMER HAD DISCONNECTED FOR THE INSULIN PUMP AND WAS ON INTRAVENOUS FLUID TREATMENT. THEY STATED THAT THEY HAD NOT USED THE SENSOR IN A COUPLE OF MONTHS. AT THE TIME OF THE PHONE CALL THE CUSTOMER'S BLOOD GLUCOSE WAS 202 MG/DL. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE HOSPITALIZATION. THE DISCONTINUATION OF THE INSULIN PUMP WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572104 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization