BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAB

    MDR report key: 8022549 · Received October 31, 2018

    Report

    Report Number
    2032227-2018-52791
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 14, 2018
    Report Date
    January 21, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169513051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO PARTIAL UNLOCKED KEYPAD CONNECTOR NOTED DURING VISUALLY INSPECT. UNABLE TO PERFORM ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT, OPERATING CURRENTS, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST DUE TO BUTTONS NOT RESPONDING.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND THE INSULIN PUMP HAD A BUTTON ERROR AND BUTTONS WERE NOT WORKING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 402, 223, 180 AND 360 MG/DL. ADDITIONALLY THE BLOOD GLUCOSE VALUE WAS 180MG/DL WHICH SHOT UP TO 300MG/DL. CUSTOMER DECLINED TO TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE TIME WAS ADVANCES. THE CUSTOMER WAS ADVISED 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
    865408 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAB PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523RNAB A1523RNABJ 00643169513051

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR