BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920048 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86514
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    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

    CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE LEVELS KEPT INCREASING EVEN AFTER HIS BOLUS. CUSTOMER STATED THAT AT BED TIME HIS BLOOD GLUCOSE LEVEL WAS 231 MG/DL. CUSTOMER WOKE UP WITH THE PARAMEDICS AROUND HIM. CUSTOMER FEELS THAT THE INSULIN PUMP WAITED TO DELIVER ALL HIS BOLUSES UNTIL HE WENT TO BED. CUSTOMER STATED THAT HIS BLOOD GLUCOSE READING WAS 26 MG/DL WHEN THE PARAMEDICS ARRIVED AND THEY WERE ABLE TO BRING IT UP TO 150 MG/DL BEFORE THEY LEFT. CALLER ALSO REPORTED THAT THE PARAMEDICS HAVE BEEN CALLED THREE TIMES IN THE PAST SIX WEEKS DUE TO LOW BLOOD GLUCOSE LEVELS. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 437 MG/DL. TROUBLESHOOTING WAS PERFORMED AND DRIVE SUPPORT CAP AND ALL SETTINGS APPEARED TO BE NORMAL. SELF TEST ALSO PASSED. CUSTOMER ALSO REPORTED DIFFICULTY REMOVING BATTERY CAP. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396606 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention