BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3833525 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-85028
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 13, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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.

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT PARAMEDICS WERE CALLED FIVE TIMES AND SHE HAD BEEN TO THREE TO FOUR HOSPITALS. BLOOD GLUCOSE LEVELS WERE 204 MG/DL AT THE TIME OF CALL. IN THE PREVIOUS ONE TO TWO WEEKS, CUSTOMER HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS WHICH WERE TREATED BY DRINKING LOTS OF MILK. CUSTOMER WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE LEVELS OF 40-45 MG/DL. CUSTOMER WAS EXPERIENCING SHAKING AND FEELINGS OF GOING UNCONSCIOUS. DURING TROUBLESHOOTING CUSTOMER STATED THAT THE BASAL RATES WERE RECENTLY CHANGED AND SEEMS TO BE TOO HIGH. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310249 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization