BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4822971 · Received June 6, 2015

    Report

    Report Number
    2032227-2015-18127
    Event Type
    Malfunction
    Date Received
    June 6, 2015
    Date of Event
    May 16, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED A MOTOR ERROR ALARM DURING A PRIME. CUSTOMER'S BLOOD GLUCOSE WAS 250 MG/DL. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. CUSTOMER ALSO STATED THEY WERE UNABLE TO COMPLETE THE REWIND SEQUENCE ON THEIR INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366713 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR