BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 8685860 · Received June 11, 2019

    Report

    Report Number
    2032227-2019-14221
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    June 3, 2019
    Report Date
    August 14, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169873834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE AT ELECTRONIC ASSEMBLY. DEVICE FOUND MOISTURE DAMAGE AT MOTOR ASSEMBLY NOTED.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150 MG/DL. THE CUSTOMER REPORTED THAT THEY CHANGED THE BATTERY AND INSULIN PUMP SCREEN WAS BLANK. THE CUSTOMER STATED THAT THE BATTERY GOT LOW AND WHEN REPLACED THE BATTERY THE PUMP DIDN'T TURN. THE TROUBLESHOOTING WAS PERFORMED AND WAS ADVISED TO INSERT ANEW BATTERY AND DISPLAY DID NOT RETURN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483017 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG1R7MD 00643169873834

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR