BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780K 670G 3ML BLACK

    MDR report key: 8702850 · Received June 17, 2019

    Report

    Report Number
    2032227-2019-16836
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    June 8, 2019
    Report Date
    August 13, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED CONSTANT PUMP ERROR 130 ALARM DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. UNABLE TO VERIFY PUMP ERROR 43 ALARM DUE TO PUMP ERROR 130 ALARM.

    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 AN INSULIN PUMP ERROR ALARMS MULTIPLE TIMES. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM BUT WAS NOT ABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS JAMMED. IF THEY PRESSED THE REWIND, THE INSULIN PUMP WILL SHUTDOWN AND IT WILL GO BACK TO REWIND. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496226 PUMP MMT-1780K 670G 3ML BLACK ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780K HG1XS8A 00643169939202

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR