BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233574 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-31205
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED FAILED BATTERY TEST ALARM NOTED. UNIT PASSED FUNCTIONAL TEST INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33, AND EXCESSIVE NO DELIVERY ALARM TEST. NO BACK LIGHT ANOMALY WAS NOTED. UNIT FUNCTIONED PROPERLY. UNIT RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECENTLY BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS. CUSTOMER REPORTED THAT THE HOSPITAL STAFF REMOVED THE INSULIN PUMP. BLOOD GLUCOSE LEVEL AT THE TIME OF ADMISSION WAS OVER 400 MG/DL. CUSTOMER ALSO REPORTED RECENTLY HAVING TROUBLE WITH LOW BLOOD GLUCOSE LEVELS. CUSTOMER WAS HOSPITALIZED AT THE TIME OF THE CALL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS NOT PROVIDED. TROUBLESHOOTING SHOWED THAT THE INSULIN PUMP HAD RECENTLY RETURNED A FAILED BATTERY TEST. BLOOD GLUCOSE LEVEL WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715841 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization