BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933444 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03878
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HER GLUCOSE READINGS ARE INACCURATE. SHE STATED THAT THE SENSOR GLUCOSE READING WAS 110 MG/DL WHILE THE BLOOD GLUCOSE READING WAS 243 MG/DL. LATER THE SENSOR GLUCOSE READING WAS 95 MG/DL WHILE THE BLOOD GLUCOSE READING WAS 185 MG/DL. AT THE TIME OF THE CALL, THE BLOOD GLUCOSE READING WAS 276 MG/DL. CUSTOMER REPORTED THAT THE INSULIN PUMP SHOWED IT HAD 3 BARS REMAINING OF BATTERY LIFE AND THEN SUDDENLY SHUT OFF WITHOUT ANY WARNING. THE INSULIN PUMP ALSO HAD A RECURRING FAILED BATTERY ALARM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411143 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR