BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 14021400 · Received April 6, 2022

    Report

    Report Number
    2032227-2022-176455
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    January 21, 2021
    Report Date
    April 6, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000192143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). RETAINER RING = CLEAR. CUSTOMER RETURNED PUMP FOR AN ALLEGED LOW BATTERY LIFE OR LOW BATTERY ALERT FOUND ON JAN 21, 2021. THE PUMP PASSED THE SELF TEST AND DISPLACEMENT TEST. HOWEVER, THE PUMP HAD A HIGH ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS OR ALERTS NOTED DURING THE TESTING. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 14:11:49.000, (B)(6) 2021 05:35:16.000 TO (B)(6) 2021 08:59:59.000, (B)(6) 2021 02:39:01.000 TO (B)(6) 2021 02:40:51.000, (B)(6) 2021 23:20:08.000, (B)(6) 2021 10:04:44.000, (B)(6) 2021 04:36:23.000, 01/17/2021 01:09:34.000, (B)(6) 2021 19:11:44.000 TO (B)(6) 2021 19:15:29.000, (B)(6) 2021 11:22:57.000 AND (B)(6) 2021 11:23:10.000, LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 04:36:00.000, (B)(6) 2021 19:29:00.000, 01/04/2021 08:57:00.000, 01/06/2021 16:34:00.000, (B)(6) 2021 05:42:00.000, (B)(6) 2021 00:23:00.000, 01/13/2021 19:00:00.000, 01/16/2021 15:36:00.000, (B)(6) 2021 07:13:00.000 TO (B)(6) 2021 19:15:05.000, REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 14:07:00.000, (B)(6) 2021 05:00:00.000, 01/07/2021 02:05:00.000, 01/09/2021 15:13:00.000, (B)(6) 2021 09:54:00.000, (B)(6) 2021 04:31:00.000, 01/17/2021 01:07:00.000, (B)(6) 2021 16:44:00.000 AND (B)(6) 2021 16:55:11.000, REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 05:31:00.000 AND (B)(6) 2021 05:41:00.000, (B)(6) 2021 02:36:00.000, (B)(6) 2021 15:44:00.000 AND (B)(6) 2021 15:54:00.000, (B)(6) 2021 17:15:00.000 AND (B)(6) 2021 17:25:00.000, POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 09:01:20.000, (B)(6) 2021 23:19:50.000 AND (B)(6) 2021 19:15:41.000, AND FAILED BATT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 08:54:36.000 TO (B)(6) 2021 08:59:52.000, (B)(6) 2021 02:40:41.000, (B)(6) 2021 19:10:59.000 TO (B)(6) 2021 19:15:10.000, 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 ACTIVE CURRENT MEASUREMENT AND 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 FAILED THE ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. THE PUMP HAD A HIGH ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT, PROBLEM ISOLATED ON THE PCBA 1 AND PCBA 2. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT. HOWEVER, A CRACKED RETAINER¿WAS NOTED DURING TESTING. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A STAINED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL FADING, A CRACKED RETAINER WAS CONFIRMED. LOW BATTERY LIFE OR LOW BATTERY ALERT AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WERE 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 1 AND PCBA 2. 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. 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. MAEDTRONIC 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 INDICATED THAT THE BATTERIES WERE NOT LASTING. CUSTOMER STATED THAT THE BATTERY CAP WAS INTACT AND REPLACE BATTERY ALARMS REOCCURRED EVERY 2 OR 3 DAYS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703257 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K 000000763000192143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown