BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2944565 · Received February 5, 2013

    Report

    Report Number
    2032227-2013-00464
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING UNEXPLAINED HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND LOW BATTERY ALARMS. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. ADVISED THE CALLER TO CALL BACK WHEN THE TUBING CLAMP ARRIVES TO CONTINUE TESTING. THE CUSTOMER ALSO MENTIONED BEING HOSPITALIZED DUE TO NON DIABETES RELATED ISSUES. HOWEVER, THE CUSTOMER WAS RECONNECTED THE INSULIN PUMP, AND HIS BLOOD GLUCOSE WENT UP TO 749 MG/DL. THEN THE DEVICE WAS REMOVED AND HE REVERTS TO BACK UP PLAN TO LOWER HIS SUGAR LEVEL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48099 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization