BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4230781 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48247
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    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

    CUSTOMER REPORTED THAT HE EXPERIENCED LOW BLOOD GLUCOSE OF 40 MG/DL THE NIGHT BEFORE; CUSTOMER TREATED BY DRINKING ORANGE JUICE. CUSTOMER STATED THAT HIS BLOOD GLUCOSE WHEN HE WOKE UP WAS 130. CUSTOMER WENT OUT FOR A BLOOD TEST AND BLOOD GLUCOSE WAS 170 MG/DL WHEN HE RETURNED; HE TREATED WITH THE INSULIN PUMP. CUSTOMER THEN HAD BREAKFAST AND FOR LUNCH HIS BLOOD GLUCOSE WENT TO 278 MG/DL. CUSTOMER HAD REMOVED THE INFUSION SET AND STATED THAT THE CANNULA WAS BENT. AND WHEN I HAD CALLED YOU YESTERDAY IT WAS SLIGHTLY BENT. CALL DROPPED BEFORE AND CUSTOMER COULD NOT BE REACHED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715666 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR