BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8665510 · Received June 4, 2019

    Report

    Report Number
    2032227-2019-10981
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 27, 2019
    Report Date
    July 12, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00613994743923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PASSED THE DISPLACEMENT TEST.DEVICE RECEIVED A33 ALARM DURING THE BASIC OCCLUSION TEST DUE TO LOOSE OR PROTRUDED DRIVE SUPPORT DISK. UNABLE TO PERFORM PRIME OR A33 TEST, EXCESSIVE NO DELIVERY TEST AND OCCLUSION TEST DUE TO A33 ALARM. DEVICE RECEIVED WITH LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER WAS NOT ASSISTED WITH TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462607 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP A3723NAPJ 00613994743923

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR