BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3160730 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-94609
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 BEING IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 545MG/DL. THE CUSTOMER STATED THAT THEY CHECKED AND WAS TOLD THAT EVERYTHING WAS FINE. THE CALLER STATED THAT SHE WAS CHANGING THE INFUSION SET, AND THEN SUDDENLY TWO HOURS LATER HIS GLUCOSE LEVEL WAS ELEVATED. THEN SHE CHANGED THE INFUSION SET AGAIN, AND SHE DID NOT EAT THE DAY BEFORE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261180 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 48 YR Hospitalization UNOMEDICAL INFUSION SET