BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 11911371 · Received June 1, 2021

    Report

    Report Number
    2032227-2021-151381
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 26, 2021
    Report Date
    October 15, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSULIN PUMP WAS RECEIVED WITH A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A CRACKED KEYPAD OVERLAY, A STAINED KEYPAD OVERLAY, A CRACKED CASE-CORNER OF BELT CLIP RAILS, A PILLOWING KEYPAD OVERLAY AND A SERIAL NUMBER LABEL FADING. THE TEST P-CAP/RESERVOIR DOES LOCK PROPERLY INSIDE THE RESERVOIR TUBE. THE INSULIN PUMP PASSED THE SELF TEST, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. NO UNEXPECTED PUMP ERROR 130 ALARM NOTED DURING THE TESTING. THE INSULIN PUMP HISTORY FILE/TRACES DOWNLOAD WAS SUCCESSFUL USING THUS. PUMP ERROR 130 ALARM WERE RECORDED AND FOUND IN THE DOWNLOADED HISTORY FILES ON (B)(6) 2021 08:12:45.000 ALARM ALERT NOTIFICATION, (B)(6) 2021 08:13:44.000 ALARM ALERT NOTIFICATION, (B)(6) 2021 08:22:00.000 ALARM ALERT NOTIFICATION, (B)(6) 2021 08:26:57.000 ALARM ALERT CLEARED, (B)(6) 2021 08:26:57.000 ALARM ALERT CLEARED AND PUMP ERROR 37 ALARM ON (B)(6) 2021 16:53:00.000 ALARM ALERT NOTIFICATION AND (B)(6) 2021 16:54:23.000 ALARM ALERT CLEARED, PROBLEM ISOLATED ON THE MOTOR ASSEMBLY. NO PUMP ERROR 38, 39, 41, 42, 43, 79, 80 AND 82 ALARM ON THE DEVICE HISTORY NOTED. 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. THE FORCE SENSOR ZERO OFFSET MEASURED (23.2 MILIVOLTS) AND WITHIN SPECIFIC RANGE. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. 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

    THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. (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 PUMP ERROR ALARM. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND THEY WERE UNABLE TO REWIND INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. 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
    813972 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG40YSJ 000000763000317140

    Patients

    Seq Age Sex Outcome Treatment
    1