BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL -TIME INSULIN INFUSION PUMP

    MDR report key: 4131248 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26076
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 20, 2014
    Report Date
    June 27, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIM INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP MONITORED FOR SEVERAL DAYS AND NO BLANK DISPLAY NOTED. INSULIN PUMP RECEIVED WITH NORMAL OPERATING CURRENT. PUMP PASSED SELF TEST. INSULIN PUMP PASSED OFF NO POWER TEST. NO UNEXPECTED LOW BATTERY ALARM ANOMALIES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP HAD CONSTANT LOW BATTERY ISSUES. A BATTERY CAP HAS BEEN PREVIOUSLY SENT AND ISSUE PERSISTED. CUSTOMER STATED CUSTOMER HAD CHANGED THE BATTERY ON FOUR OCCASIONS AND THEY ONLY LAST THREE DAYS. CUSTOMER'S BLOOD GLUCOSE WAS 10.1 MMOL/L. NO FURTHER INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584867 PARADIGM REAL -TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-754LWWP

    Patients

    Seq Age Sex Outcome Treatment
    1