BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4821265 · Received June 5, 2015

    Report

    Report Number
    3004209178-2015-62922
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE CUSTOMER REPORTED VIA PHONE CALL EXPERIENCING LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE WAS 40 MG/DL, WHICH THE CUSTOMER TREATED WITH JUICE AND BROUGHT UP TO 59 MG/DL. THE CUSTOMER CHECKED AGAIN AND REPORTED THAT HER BLOOD GLUCOSE WAS 89 MG/DL. SHE STATED THAT SHE HAD GIVEN HERSELF TOO MUCH INSULIN EARLIER, LEADING TO THE LOW BLOOD GLUCOSE EVENT. SHE NOTED THAT SHE WAS USING U500 INSULIN AND WAS ADVISED THAT THE INSULIN PUMP WAS MADE FOR U100 INSULIN. SHE WAS ADVISED TO CONSULT A DOCTOR TO SEE IF ANY ADJUSTMENTS NEEDED TO BE MADE. SHE STATED THAT SHE KNEW WHY SHE HAD LOW BLOOD GLUCOSE AND DECLINED TROUBLESHOOTING ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365422 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 72 YR