BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4140789 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-32696
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST AND EXCESSIVE NO DELIVERY TEST. UNIT HAD A SMALL CRACK IN THE BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE READINGS OF 500 MG/DL. CUSTOMER REPORTED SYMPTOMS OF FEELING TIRED, SLEEPY AND HAVING DEHYDRATION. CUSTOMER WAS TREATED WITH IV AND INSULIN SHOTS AT THE HOSPITAL. CANNULA WAS NOTED TO BE OCCLUDED. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 300 MG/DL AND HAS TREATED WITH AN INSULIN PEN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620122 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization