BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2800727 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-90278
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    October 13, 2012
    Report Date
    October 13, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING UNEXPLAINED HIGH BLOOD GLUCOSE OVER 300MG/DL, AND HIS BLOOD GLUCOSE WAS TREATED WITH BOLUS AND MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS HISTORY WERE CORRECT. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. THE HIGH PRESSURE TEST WAS PERFORMED, AND THE TEST FAILED TWICE. THE CUSTOMER STATED THAT THE REMOVES THE REMOVES THE RESERVOIR FROM THE INSULIN PUMP SEVERAL TIMES. ADVISED THE CUSTOMER THAT THE DEVICE WOULD BE REPLACED AND REVERT TO BACK UP PLAN. THE CALLER ALSO MENTIONED LOOSING WEIGHT AND HAVING CURRENTLY LOW BLOOD GLUCOSE OF 47MG/DL. THE CUSTOMER STATED THAT HE IS FEELING WELL, AND HIS LOW BLOOD GLUCOSE WILL BE TREATED WITH GLUCOSE TABLETS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR