BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 12292375 · Received August 9, 2021

    Report

    Report Number
    2032227-2021-177837
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 29, 2021
    Report Date
    October 24, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSULIN PUMP WAS RECEIVED WITH A SCRATCHED CASE, A PILLOWING KEYPAD OVERLAY AND A SERIAL NUMBER LABEL FADING. THE TEST P-CAP/RESERVOIR DOES LOCK PROPERLY INSIDE THE RESERVOIR TUBE. THE CREST AND THUS SOFTWARE DOWNLOADS WERE UTILIZED AND SUCCESSFUL. THE INSULIN PUMP WAS ALSO RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM, PUMP ERROR 3 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILES ON (B)(6) 2021 12:35:26.000 ALARM ALERT NOTIFICATION AND (B)(6) 2021 12:35:40.000 ALARM ALERT CLEARED, PUMP ERROR 53 ALARM (LINE NUMBER = 5632 ; FILE NUMBER = 2005) ON (B)(6) 2021 12:36:50.000 ALARM ALERT NOTIFICATION AND (B)(6) 2021 12:37:12.000 ALARM ALERT NOTIFICATION AND PUMP ERROR 54 ALARM (LINE NUMBER = 1421, FILE NUMBER = 32122) ON (B)(6) 2021 12:35:24.000 ALARM ALERT NOTIFICATION DUE TO SOFTWARE ERROR. THE INSULIN PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND NO LOOSE ELECTRONIC COMPONENTS OR MOISTURE DAMAGE FOUND ON THE ELECTRONIC ASSEMBLY, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A CRITICAL PUMP ERROR ALARM. CUSTOMER STATED THEY HAD OPEN BOOK IMAGE ON THE SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191988 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4MQS7 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR