BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4150325 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35134
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 266 MG/DL. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READING KEPT DROPPING, FROM 86 MG/DL AT 1:30 PM, TO 54 MG/DL ABOUT FIFTEEN MINUTES LATER, THEN DOWN TO 39 MG/DL AFTER SHE ATE CANDY; FIFTEEN MINUTES THEREAFTER, THE BLOOD GLUCOSE READING WAS 37 MG/DL, WHICH SHE TREATED WITH ORANGE JUICE. THE RESERVOIR SHOWED THE SAME AMOUNT OF INSULIN AS WAS SHOWN ON THE STATUS SCREEN. AFTER TROUBLESHOOTING, ADVISED THE CUSTOMER TO DISCUSS THE LOW BLOOD GLUCOSE LEVELS WITH HER DOCTOR. SHE CALLED AGAIN REPORTING ANOTHER LOW BLOOD GLUCOSE READING IN THE 30 TO 40 MG/DL RANGE, AS WELL AS SOME HIGH BLOOD GLUCOSE EVENTS. SHE REPORTED THAT HER BLOOD GLUCOSE LEVELS WERE FLUCTUATING DUE TO HER NOT KNOWING HOW TO COUNT THE CARBOHYDRATES ACCURATELY. SHE REQUESTED TRAINING ON THE SUBJECT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629222 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR