BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722WWB

    MDR report key: 8806740 · Received July 19, 2019

    Report

    Report Number
    2032227-2019-32840
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    July 10, 2019
    Report Date
    July 19, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00613994402004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 140 MG/DL. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP WERE NOT MISSING OR DAMAGED. CUSTOMER STATED BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATES THE SPRING WAS NEITHER DAMAGED NOR CORRODED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DISPLAY DID NOT RETURNED BACK. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600842 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722WWB PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWB B2722WWBJ 00613994402004

    Patients

    Seq Age Sex Outcome Treatment
    1