BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3192669 · Received June 27, 2013

    Report

    Report Number
    2032227-2013-02602
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 CALLED TO REPORT HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT HE HAS CHANGED THE INFUSION SET, BUT CONTINUES TO EXPERIENCE ELEVATED BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER REMOVED THE CANNULA, AND THE CANNULA WAS BENT. THE CUSTOMER STATED THAT HE NEVER RECEIVED A NO DELIVERY ALARM. REVIEWED THE PROGRAMMING, AND THE TIME AND DATE WERE CORRECT. HOWEVER, THE CUSTOMER DIDN'T KNOW IF THE BASAL RATES WERE CORRECT. ADVISED THE CUSTOMER TO SPEAK WITH HIS HCP. THE CUSTOMER WAS UNABLE TO CONDUCT THE HIGH PRESSURE TEST, AS HE JUST HAD EYE SURGERY, AND WAS HAVING TROUBLE SEEING. THE CUSTOMER STATED HE WOULD CALL BACK. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294671 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR