BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711B

    MDR report key: 8825870 · Received July 25, 2019

    Report

    Report Number
    2032227-2019-36086
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 25, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169554917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. 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 BATTERY ERROR ALARM COMES UP WITH NO LEADING EVENT, AS WELL AS WHEN THE CUSTOMER TRIES TO INSERT BATTERY, THE INSULIN PUMP WOULD NOT ACCEPT IT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 5.5 MMOL/L AT THE TIME OF THE INCIDENT. THE CUSTOMER DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM. THE CUSTOMER STATED THAT THE BATTERY WAS NOT PREVIOUSLY USED. THE CUSTOMER INFORMED THAT THE BATTERY CAP WAS NOT LOOSE, CRACKED OR DAMAGED. THIS WAS THE SECOND OCCURRENCE OF REPLACE BATTERY ALERT OR REPLACE BATTERY NOW WITHOUT A LOW BATTERY WARNING. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED THAT THEY MAY CONTINUE TO WEAR THE INSULIN PUMP UNTIL REPLACEMENT ARRIVES IF THEY INSERT A NEW BATTERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619786 640G INSULIN PUMP MMT-1711B PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711B HG0NSKS 00643169554917

    Patients

    Seq Age Sex Outcome Treatment
    1