BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 12785811 · Received November 10, 2021

    Report

    Report Number
    2032227-2021-216355
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    July 14, 2021
    Report Date
    November 10, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING=BLACK. CUSTOMER COMPLAINED ON (B)(6) 2021 PUMP ALARMED PUMP ERROR 23. PUMP PASSED SELF TEST AND DISPLACEMENT TEST. NO PUMP ERROR 23 NOTED DURING TEST. UNIT SUCCESSFULLY DOWNLOADED TO THUMPS. VERIFIED IN PUMP ALARMED PUMP ERROR 23 AT (B)(6) 2021 14:03:11.000 IN PUMP DOWNLOADED HISTORY DUE TO INSULIN DELIVERY STOP DUE TO PUMP ALARMING PUMP ERROR 15. PUMP ERROR 15 ALARM ((B)(4)) IS FOUND IN THE FORMATTED HISTORY FILE ON (B)(6) 2021 14:03:09.000 DUE TO A MOISTURE DAMAGE TO PCB1 BOARD AND PCB2 BOARD AS PER GLOBAL LOGIC ANALYSIS ((B)(4)). NO MOISTURE DAMAGE NOTED ON MOTOR ASSEMBLY DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE P-CAP DOES LOCK PROPERLY. NO PUMP ERROR 23 NOTED DURING TEST. VERIFIED IN PUMP ALARMED PUMP ERROR 23 AT (B)(6) 2021 14:03:11.000 IN PUMP DOWNLOADED HISTORY DUE TO INSULIN DELIVERY STOP DUE TO PUMP ALARMING PUMP ERROR 15. PUMP ERROR 15 ALARM ((B)(4)) IS FOUND IN THE FORMATTED HISTORY FILE ON (B)(6) 2021 14:03:09.000 DUE TO A MOISTURE DAMAGE TO PCB1 BOARD AND PCB2 BOARD AS PER GLOBAL LOGIC ANALYSIS ((B)(4)). (B)(4).

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SHOWED AN INSULIN PUMP ERROR TWICE. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ALSO COMPLETE INSULIN PUMP REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682695 PUMP MMT-1880L MM770G BLE MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L HG59ZQS 000000763000439866

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female