BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711W

    MDR report key: 8784014 · Received July 12, 2019

    Report

    Report Number
    2032227-2019-28996
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    February 6, 2019
    Report Date
    July 12, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED DISPLACEMENT, AND SELF TESTS; IT FAILED ACTIVE CURRENT MEASUREMENT, AND SLEEP CURRENT MEASUREMENT TESTS. AFTER FURTHER REVIEW THERE ARE TRACES OF PREVIOUS MOISTURE PRESENCE ON PCBA1 ON THE BACK OF THE LCD DISPLAY. IN ADDITION TO THIS, THERE ARE SLIGHT TRACES OF CORROSION ALONG THE TOP OF THE BATTERY COMPARTMENT. DID NOT NOTE ANY CRACKS IN THE CASE. FURTHERMORE, THE RETAINER RING IS SOLIDLY INTACT WITH THE RESERVOIR TUBE LIP. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640 G 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 CUSTOMER'S INSULIN PUMP RECEIVED REPLACE BATTERY NOW ALERT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 9 MMOL/L AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED IN TROUBLESHOOTING. THE CUSTOMER DID RECEIVE LOW BATTERY ALERT BEFORE REPLACE BATTERY NOW ALERT. THE CUSTOMER ALSO STATED THAT THIS WAS THE SECOND OCCURRENCE OF THE ALERT. THEY ALSO REPORTED THAT THE BATTERY WAS NOT PREVIOUSLY USED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577177 640G INSULIN PUMP MMT-1711W PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711W HG1784V

    Patients

    Seq Age Sex Outcome Treatment
    1