BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4260119 · Received November 18, 2014

    Report

    Report Number
    2032227-2014-54503
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    August 9, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. REFERENCE MANUFACTURER REPORT NUMBER: 2032227-2014-54504.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER WAS RECEIVING NO DELIVERY ALARMS. CUSTOMER ALSO REPORTED THEIR BLOOD GLUCOSE REMINDER WAS ALSO NOT FUNCTIONING. THE CUSTOMER ALSO REPORTED HAVING A LOW BLOOD GLUCOSE EVENT WHERE THEIR BLOOD GLUCOSE DECLINED TO 24 MG/DL. THE CUSTOMER'S BLOOD GLUCOSE WAS 175 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER ALSO REPORTED A MOTOR ERROR ALARM THAT OCCURRED DURING A BOLUS DELIVERY. CUSTOMER ALSO STATED THEY WERE ABLE TO COMPLETE THE REWIND SEQUENCE ON THEIR INSULIN PUMP. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746450 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR