BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3240725 · Received July 22, 2013

    Report

    Report Number
    2032227-2013-03085
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 30, 2013
    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

    CUSTOMER REPORTED THAT SHE HAD UNEXPLAINED HIGH AND LOW BLOOD GLUCOSE. CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM AND WAS HOSPITALIZED TWO DIFFERENT TIMES. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EMERGENCY ROOM VISIT FOR HIGH BLOOD GLUCOSE ON (B)(6) 2013 WAS 274 MG/DL. LOW BLOOD GLUCOSE READING ON (B)(6), 2013 WAS 43 MG/DL WHEN PARAMEDICS ARRIVED AND 117 MG/DL AT THE TIME OF HOSPITALIZATION. CUSTOMER STATED THAT SHE WAS IN A CAR ACCIDENT AND SHE WAS THE DRIVER AT THE TIME OF THE ACCIDENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341923 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization