BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWS

    MDR report key: 8845150 · Received July 31, 2019

    Report

    Report Number
    2032227-2019-38931
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    August 29, 2018
    Report Date
    July 31, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169304741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSULIN PUMP RECEIVED WITH CRACKED AND BLEEDING LCD GLASS. UNABLE TO PERFORM THE DISPLACEMENT DUE TO PHYSICAL DAMAGED TO LCD GLASS. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD CRACKED ON THE RESERVOIR COMPARTMENT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 139 MG/DL AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WAS NEITHER BUMPED NOR DROPPED. THE DRIVE SUPPORT CAP WAS NOT DAMAGED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642553 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWS 00643169304741

    Patients

    Seq Age Sex Outcome Treatment
    1