BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722CAS

    MDR report key: 8743302 · Received June 28, 2019

    Report

    Report Number
    2032227-2019-22645
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    June 23, 2019
    Report Date
    October 10, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169919389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    DEVICE POWER UP PROPERLY AFTER BATTERY INSTALLATION. NO BLANK DISPLAY NOTED. HOWEVER, DEVICE RECEIVED WITH FROZEN SCREEN STUCK AT NUMBER 2, PROBLEM ISOLATED TO MOTHER BOARD. UNABLE TO PERFORM THE SELF-TEST, A21 ERROR TEST, DISPLACEMENT TEST DUE TO FROZEN SCREEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND THE DISPLAY DID NOT RETURN. CUSTOMER STATES BATTERY COMPARTMENT IS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATES THE SPRING IS NEITHER DAMAGED NOR CORRODED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE CUSTOMER WAS ADVISED THE PUMP WILL BE REPLACED AS PER TROUBLESHOOT. THE INSULIN PUMP WILL BE RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536794 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722CAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722CAS B4722CASJ 00643169919389

    Patients

    Seq Age Sex Outcome Treatment
    1