BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751NAH

    MDR report key: 8057866 · Received November 10, 2018

    Report

    Report Number
    2032227-2018-58424
    Event Type
    Malfunction
    Date Received
    November 10, 2018
    Date of Event
    October 28, 2018
    Report Date
    February 6, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503687
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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.

    Additional Manufacturer Narrative · 1

    DEVICE POWER UP PROPERLY AFTER BATTERY INSTALLATION. NO BLANK DISPLAY NOTED. UNIT WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND PASSED SELF-TEST, UNEXPECTED RESTART ERROR TEST AND DISPLACEMENT TEST. NO UNEXPECTED OFF NO POWER, LOW BATTERY, WEAK BATTERY, BATTERY OUT LIMIT AND FAILED BATTERY TEST ALARMS NOTED DURING TESTING. DEVICE HAD MINOR CRACKED LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 560 MG/DL AT TIME OF INCIDENT AND ALSO THEY STATED THAT BLOOD GLUCOSE WENT TO IN BETWEEN 800-120 MG/DL. CUSTOMER TREATED WITH INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED FOR HIGH BLOOD GLUCOSE LEVEL. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897714 530G INSULIN PUMP MMT-751NAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH A4751NAHJ 00643169503687

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other