BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 10702898 · Received October 20, 2020

    Report

    Report Number
    2032227-2020-193115
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    October 9, 2020
    Report Date
    October 19, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000166526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. 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

    COMPLAINTS TEXT: ON 10/09/2020 AT 09:52:12. ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT ON 10/09/2020, AT 09:47:54. (B)(4) REFERENCED REPORT PROVIDED TO MEDTRONIC (POS DEPARTMENT ON 10/08/2020- FORWARDED TO MEDTRONIC 24-HOUR TECHNICAL SUPPORT DEPARTMENT / INCIDENT DATE FROM (B)(6) 2020. MALFUNCTIONS: BATTERY LIFE DIMINISHED, NO DELIVERY ALARMS COMPLAINS: REPEATED BG LOOPS, CALIBRATION FOR NO REASON. DECLINED TRANSFER TO 24 HR HLP LINE --END REPORT--- 1ST ATTEMPT: SUCCESSFUL PATIENT SAYS SHE CANNOT TALK RIGHT NOW PATIENT REQUEST FOR A CALL BACK LATER ADVISED THE PATIENT THAT SOMEONE WILL CALL HER LATER TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171111 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG3NLFM 000000763000166526

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR