BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920258 · Received July 8, 2014

    Report

    Report Number
    2032227-2014-03140
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 PATIENT CALLED TO REPORT MULTIPLE NO DELIVERY ALARMS FOR THE PAST FOUR DAYS. THE PATIENT HAS CLEARED THE ALARMS AND EVEN CHANGED THE BATTERY, BUT CONTINUES TO GET THE ALARMS. THE PATIENT ALSO REPORTED CRACKS ALONG THE RESERVOIR CHAMBER OF THE PUMP. THE PATIENT STATED SHE WAS IN A CAR ACCIDENT, AND WAS HOSPITALIZED ON (B)(6) 2014 WITH A BG OF 800 MG/DL. THE PATIENT STATED SHE WAS TREATED AND RELEASED. DURING THE CALL, THE PATIENT WAS EXPERIENCING HIGH BGS, AND COULDN'T TREAT DUE TO THE NO DELIVERY ALARMS. OFFERED TO CALL THE PARAMEDICS SEVERAL TIMES, BUT THE PATIENT DECLINED. SHE ONLY WANTED THE PUMP REPLACED. ADVISED THAT PUMP WAS OUT OF WARRANTY, AND GAVE HER THE OPTIONS SHE HAD. THE PATIENT DID NOT AGREE TO THE TERMS. TROUBLESHOOTING WAS PERFORMED, AND THE PUMP PASSED THE PRIME TEST. REMOVED THE INFUSION SET, AND FOUND THAT THERE WAS BLOOD IN THE CANNULA. ADVISED THAT THE BLOOD COULD HAVE BEEN THE REASON FOR THE NO DELIVERY ALARMS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397639 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization