BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945836 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87960
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED FUNCTIONAL TEST INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33, AND EXCESSIVE NO DELIVERY ALARM TEST. UNIT FUNCTIONED PROPERLY. UNIT RECEIVED WITH SCRATCHED LCD WINDOW, SEVERELY CRACKED RESERVOIR TUBE, BROKEN RESERVOIR TUBE LIP, BROKEN BELT CLIP SLOT, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS AND DIABETES KETOACIDOSIS. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE HOSPITALIZATION WAS OVER 600 MG/DL AND WAS TREATED WITH INSULIN DRIPS. CUSTOMER REPORTED SYMPTOMS OF NAUSEA, VOMITING, EXCESSIVE THIRST, URINATION AND ABDOMINAL PAIN PRIOR TO THE HOSPITALIZATION. RESERVOIR COMPARTMENT WAS NOTED TO BE BROKEN. THE CALLER STATED THAT WHEN THE CUSTOMER TRIES TO BOLUS HE DOES NOT RECEIVE INSULIN. IT WAS ALSO NOTED THAT THE CANNULA WAS BENT INSIDE THE CUSTOMER'S BODY. NO FURTHER INFORMATION REPORTED. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426004 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization