BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4844568 · Received June 15, 2015

    Report

    Report Number
    2032227-2015-18985
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    May 26, 2013
    Report Date
    May 27, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 THAT HE RECENTLY HAD A BLOOD GLUCOSE LEVEL OF 36 MG/DL WHICH PARAMEDICS WERE CALLED TO RESPOND TO. CUSTOMER REPORTED THAT HE WAS NOT TRANSPORTED TO A HOSPITAL, JUST TREATED BY PARAMEDICS. THE CUSTOMER STATED THAT AT THE TIME OF THE INCIDENT, HIS SENSOR GLUCOSE READING WAS 100 MG/DL. THE CUSTOMER REPORTED TREATING WITH ORANGE JUICE. CUSTOMER STATED THAT HE EXPERIENCED TWO TO THREE LOW BLOOD GLUCOSE EVENTS WITHIN TWO TO THREE WEEKS. THE CUSTOMER REPORTED THAT EARLIER ON THE DAY OF THE CALL, HE WOKE UP WITH A BLOOD GLUCOSE LEVEL OF 300 MG/DL AND TREATED WITH THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED RECEIVING A WEAK SIGNAL ALERT. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS 63 MG/DL. THE CUSTOMER WILL NOT RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387311 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention