BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 6850202 · Received September 7, 2017

    Report

    Report Number
    2032227-2017-45649
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Date of Event
    August 18, 2017
    Report Date
    September 7, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169739512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 VIA PHONE CALL THAT THEY SWAM IN THE SEA WITH THE INSULIN PUMP ON. AFTER THEY LEFT THE SEA, THE INSULIN PUMP HAD AUTOMATICALLY TURNED OFF. THEY DID NOT RECEIVE ANY ALARMS. THEY TRIED TURNING ON THE DEVICE WITH A NEW BATTERY BUT IT DID NOT WORK. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630687 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG1LGK0 00643169739512

    Patients

    Seq Age Sex Outcome Treatment
    1