BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4181239 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39486
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014 FOR HIGH BLOOD GLUCOSE LEVELS OF 650 MG/DL. CUSTOMER TREATED WITH A BOLUS USING THE PUMP. CUSTOMER HAD THE FOLLOWING SYMPTOMS: FATIGUE, THIRST, AND IRRITABILITY. CUSTOMER STATED THAT WHEN SHE WOKE UP FROM BEING ASLEEP, HER BLOOD GLUCOSE WOULD NOT READ. CUSTOMER WOKE UP AT 6AM AND TRIED TO BOLUS TO GET IT TO GO DOWN, BUT IT WOULD NOT COME DOWN. CUSTOMER DECIDED TO GO TO THE HOSPITAL. CUSTOMER WAS GIVEN FLUIDS AND INSULIN. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF THE EMERGENCY ROOM VISIT. CUSTOMER RAN A MANUAL PRIME AND THE INSULIN DID EXIT THE TUBING. PUMP SETTINGS AND ALARM HISTORY WERE REVIEWED AND LOW BATTERY AND LOW RESERVOIR ALARMS WERE FOUND. CUSTOMER WAS ADVISED THAT THE PUMP IS FUNCTIONING CORRECTLY. CUSTOMER STATED THAT YESTERDAY SHE RECEIVED A NO DELIVERY ALARM YESTERDAY AND SHE CLEARED THE ALARM AND UNTANGLED THE TUBING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662234 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 29 YR Hospitalization