BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3894860 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03355
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2014. BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS OVER 600 MG/DL. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE HOSPITALIZATION. THE CUSTOMER MENTIONED THAT THE INSULIN PUMP WAS NOT ALARMING WHEN IT SHOULD. CUSTOMER ALSO MENTIONED A PREVIOUS HOSPITALIZATION A YEAR AGO ALSO RELATED TO MISSING ALARMS AND HIGH BLOOD GLUCOSE. THE CURRENT BLOOD GLUCOSE READING IS 600 MG/DL. THE CUSTOMER HAS TREATED WITH MANUAL INJECTION. THE CUSTOMER HAS BEEN OFF THE INSULIN PUMP SINCE (B)(6) 2014. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP DID NOT PASS ALL FUNCTIONAL TESTS. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370497 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization