BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4150358 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35026
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED DISPLAY WINDOW, MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION. PUMP PASSED FUNCTIONAL TEST INCLUDING PRIME/A33, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. PUMP WAS NOT RECEIVED WITH ORIGINAL BATTERY CAP. NO CORROSION NOTED IN BATTERY TUBE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN EMERGENCY ROOM VISIT DUE TO HIGH BLOOD GLUCOSE READINGS OF OVER 600 MG/DL AND DIABETES KETOACIDOSIS. IT WAS NOTED THAT THE CUSTOMER WENT INTO DIABETES KETOACIDOSIS DUE TO THE INSULIN PUMP NOT BOLUSING. CUSTOMER WAS BEING TREATED WITH INSULIN DRIPS AT THE HOSPITAL. THE BATTERY COMPARTMENT WAS NOTED TO BE CORRODED AND CUSTOMER WAS UNABLE TO REMOVE IT. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629252 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization