BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5054811 · Received September 3, 2015

    Report

    Report Number
    2032227-2015-39117
    Event Type
    Injury
    Date Received
    September 3, 2015
    Date of Event
    May 13, 2015
    Report Date
    August 13, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF 436 MG/DL. THE CUSTOMER DID NOT MENTION ANY FORM OF TREATMENT FOR THEIR BLOOD GLUCOSE LEVELS. CUSTOMER STATED THAT THEIR METER WAS NOG GIVING CORRECT READINGS. THE CUSTOMER WAS GIVEN THE CORRECT CONTACT INFORMATION TO ADDRESS THE ISSUE WITH THEIR METER. THE CUSTOMER DID NOT RETURN THE PRODUCT BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585878 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other