BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8685830 · Received June 11, 2019

    Report

    Report Number
    2032227-2019-14192
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    June 5, 2019
    Report Date
    July 15, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    UDI-DI
    00643169221567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE PASSED THE DISPLACEMENT AND SELF TEST. NO AUDIO/VIBRATE ANOMALY/ABSENCE OF ALARM NOTED DURING TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT BEEP AND VIBRATE WAS NOT WORKING. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 95 MG/DL. THE INSULIN PUMP WAS SET TO VIBRATE. CUSTOMER STATED THAT THEY WERE NOT HAVING TROUBLE HEARING THE BEEPS. ASSISTED CUSTOMER IN PERFORMING A SELF-TEST. THE INSULIN PUMP DID NOT BEEP DURING THE TONE TEST. CUSTOMER ADVISED THE PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483006 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAB PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-723RNAB A000290053 00643169221567

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR