BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4110555 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27393
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE INSULIN PUMP HAS ALARMED NO DELIVERY MULTIPLE TIMES. CUSTOMER STATED SHE CHANGED THE INFUSION SET, PRIMED IT AND INSULIN COMES OUT OF THE TUBING AND THEN SHE CHANGED IT AGAIN AND IT KEEPS GIVING HER THE NO DELIVERY ALARM. CUSTOMER BELIEVES THAT THE NO DELIVERY ALARMS ARE THE CAUSE OF HER HIGH BLOOD GLUCOSE. BLOOD GLUCOSE VALUE IS 355 MG/DL; TREATED WITH MANUAL INJECTION. CUSTOMER HAS NOT TRIED DIFFERENT CANNULA LENGTHS. THE INSULIN IS NOT EXPIRED OR DENATURED AND SHE ROTATES SITES. CUSTOMER STATED THE TUBING IS NOT BENT OR KINKED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592624 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL A2523LNALJ

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR