BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL

    MDR report key: 8825600 · Received July 25, 2019

    Report

    Report Number
    2032227-2019-35987
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    July 15, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169513129
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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 RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE AT ELECTRONIC ASSEMBLY. ALSO, MOISTURE DAMAGE MOTOR DURING VISUAL INSPECTION. UNABLE TO PERFORM OPERATING CURRENTS, SELF TEST, REWIND TEST AND DISPLACEMENT TEST DUE TO BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 252 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DISPLAY DID NOT RETURNED BACK. CUSTOMER STATED THAT THE CONTACTS ON THE BATTERY CAP WERE NOT MISSING OR DAMAGED, BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED AND SPRING IS NEITHER DAMAGED NOR CORRODED. THE CUSTOMER WAS ADVISED TO REPLACE AND TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619043 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAL A1723RNALJ 00643169513129

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR