BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1711KL 640G V4.10 BK SF MM

    MDR report key: 13705617 · Received March 9, 2022

    Report

    Report Number
    2032227-2022-122079
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    September 1, 2021
    Report Date
    March 8, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER RETURNED PUMP FOR AN ALLEGED LOW BATTERY LIFE OR LOW BATTERY ALERT FOUND ON SEPT 01, 2021. ALSO, ON (B)(4), SVN#: 000313136604 - CUSTOMER RETURNED PUMP FOR AN ALLEGED LOW BATTERY LIFE OR LOW BATTERY ALERT, UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND PUMP ERROR 23 ALARM FOUND ON AUG 24, 2021. THE PUMP PASSED THE SELF TEST, DISPLACEMENT TEST AND ACTIVE CURRENT MEASUREMENT. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. PUMP MONITORED WITHOUT THE TEST ENERGIZER BATTERY INSIDE THE BATTERY COMPARTMENT AND REINSERTS IT BACK INTO THE BATTERY COMPARTMENT FOR LESS THAN 10 MINUTES AND NO UNEXPECTED PUMP ERROR 23 ALARM NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE LOADED VOLTAGE (LOADED VLITH) AND THE UNLOADED VOLTAGE (UNLOADED VLITH) DISPLAY AT THE POWER GRAPH MANAGEMENT TOOL SHOWS ABNORMAL BEHAVIOR. NO ALARMS OR ALERTS NOTED DURING THE TESTING. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/12/2021 18:08:25.000, 08/18/2021 17:52:39.000, 08/24/2021 04:16:56.000 AND 08/24/2021 04:26:00.000. 08/25/2021 13:25:46.000, LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/12/2021 17:50:00.000, 08/18/2021 09:58:00.000, 08/23/2021 19:44:00.000, 09/01/2021 16:25:00.000, REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/18/2021 17:51:00.000, 08/24/2021 04:05:00.000 AND 08/24/2021 04:15:00.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/24/2021 04:27:19.000 AND 08/24/2021 04:27:30.000, 08/25/2021 13:26:12.000 AND 08/25/2021 13:26:23.000, PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/24/2021 04:27:03.000, 08/25/2021 13:25:58.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE ORIGINAL PCBA 2 WAS INSTALLED IN A TEST PCBA 1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP FAILED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS INSTALLED IN A TEST PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT, PROBLEM ISOLATED ON THE PCBA 2. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. PUMP ERROR 23 ALARM WAS NOT CONFIRMED. LOW BATTERY LIFE OR LOW BATTERY ALERT AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM CONFIRMED. LOW BATTERY LIFE OR LOW BATTERY ALERT AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM, PROBLEM ISOLATED ON THE PCBA 2. (B)(4). 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. 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. 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC STATED THAT THE INSULIN PUMP HAD A LOW BATTERY ALERT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE DEVISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140437 PUMP MMT-1711KL 640G V4.10 BK SF MM PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711KL HG4GRST 000000763000317119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown