BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1714K 630G BLACK MMOL CANADA

    MDR report key: 8806510 · Received July 19, 2019

    Report

    Report Number
    2032227-2019-32701
    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
    OZO
    UDI-DI
    00643169782396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NONE OF THE INSULIN PUMP BUTTONS WERE WORKING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 5.3 MMOL/L AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT NUMBERS WERE NOT RAMPING ON THEIR OWN AND THE SCROLL BAR WAS NOT MOVING WITH NO INPUT. CUSTOMER STATED MENU BUTTON WORKS AND OTHER BUTTONS WERE NOT WORKING. CUSTOMER STATED THAT THERE WAS NO RESPONSE FROM ANY BUTTON. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602897 PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1714K HG32X2N 00643169782396

    Patients

    Seq Age Sex Outcome Treatment
    1