BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 12273389 · Received August 4, 2021

    Report

    Report Number
    2032227-2021-176293
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 22, 2021
    Report Date
    February 11, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING=BLACK ON (B)(6) 2021 CUSTOMER CALLED IN WITH THE FOLLOWING CONCERN: MODERATE SCRATCHES ON THE SCREEN. BELT CLIP JAMS. BATTERY DOES NOT LAST AS LONG, REDUCED POWER LIFE. SMALL CHIP ON OUTER EDGE OF RESERVOIR SECTION. BUTTONS SOMETIMES REQUIRE PRESSING MORE THAN ONCE FOR INTENDED PURPOSE. P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. DEVICE PASSED SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT DISPLACEMENT TEST AND SELF TEST. DEVICE RECEIVED WITH ALL BUTTONS RESPONDING PROPERLY. ALL BUTTONS WERE TESTED WHILE NAVIGATING THE MENUS, AND THEY ALL WORKED PROPERLY. THUMP SOFTWARE WAS UTILIZED AND UPLOADED TRACE/HISTORY FILES PROPERLY. THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ANY 61=STUCK KEY ALARMS OR BATTERY ANOMALIES THAT MAY HAVE OCCURRED IN THE PAST. THE ADAPT TOOL REVEALS THAT NO STUCK KEY ALARMS WERE FOUND OR UNEXPECTED BATTERY ANOMALIES NOTED DURING DOWNLOAD REVIEW. THE POWER MANAGEMENT PARAMETERS GRAPH CONFIRMED THE UNLOADED VOLTAGE (UNLOADED VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPECIFIC RANGE. DEVICE RECEIVED WITH NORMAL OPERATING CURRENTS. PROCEED IT BY CUTTING DEVICE OPEN AND PERFORM A VISUAL INSPECTIONS OF CONNECTORS AND ELECTRONIC STACK. NO DAMAGE NOTED TO KEYPAD ASSEMBLY OR THE KEYPAD TRACES, AND J1 CONNECTOR ON PCB1 WAS LOCKED PROPERLY DURING VISUAL INSPECTION. THE UNIT ALSO PASSED THE KEYPAD VOLTAGE TEST (3.2V). DEVICE RECEIVED WITH MINOR SCRATCHED ON LCD WINDOW. NO DAMAGE ON BELT CLIP RAILS OR OUTER EDGE OF RESERVOIR NOTED DURING VISUAL INSPECTION. IN CONCLUSION CUSTOMER CONCERNS WERE NOT CONFIRM ON KEYPAD OR BATTERY ANOMALIES. MINOR SCRATCHED ON LCD WINDOW NOTED DURING VISUAL INSPECTION. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY. CUSTOMER STATED BUTTONS WERE SOMETIMES REQUIRE PRESSING MORE THAN ONCE FOR INTENDED PURPOSE. CUSTOMER STATED THAT INSULIN PUMP HAD SCRATCHES ON SCREEN AND BATTERY DID NOT LAST AS LONG. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175335 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4GB7N 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female