BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 15504304 · Received September 29, 2022

    Report

    Report Number
    2032227-2022-341738
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    March 19, 2018
    Report Date
    September 22, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169554931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE NGP 640G INSULIN PUMP WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN PUMP, WHICH IS MARKETED IN THE UNITED STATES. CUSTOMER RETURNED PUMP FOR AN ALLEGED COSMETIC DAMAGE LOCATED AT THE BATTERY COMPARTMENT AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM FOUND ON 19-MAR-2018. PUMP WAS RECEIVED WITH A CRACKED BATTERY TUBE THREADS AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. THE PUMP PASSED THE SELF TEST, DISPLACEMENT TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. THE PUMP WAS MONITORED FOR SEVERAL HOURS AND NO UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM NOTED. 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, LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 03/14/2018 22:50:00.000 03/18/2018 23:14:00.000 REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 03/19/2018 08:45:00.000, 03/19/2018 19:36:00.000, 03/19/2018 19:46:00.000 REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 03/19/2018 09:16:00.000, 03/19/2018 20:07:00.000, 03/19/2018 20:17:00.000 POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 03/19/2018 20:18:39.000 INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 03/19/2018 09:23:37.000, 03/19/2018 10:05:00.000 03/19/2018 10:41:59.000, 03/19/2018 20:35:18.000 AND FAILED BATT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 03/19/2018 10:05:00.000 TO 03/19/2018 10:42:20.000 03/19/2018 20:30:00.000 TO 03/19/2018 20:34:58.000 UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT, REPLACE BATTERY ALERT, REPLACE BATTERY NOW ALARM, POWER LOSS ALARM AND FAILED BATT/BATTERY FAILED ALARM WERE EXPECTED SINCE THE BATTERY HAS LOW/NO POWER. THE CUSTOMER MAY HAVE USED A LOW/DEPLETED BATTERY.PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1 AND PCBA 2. SLIGHT CORROSION WAS ALSO FOUND ON THE BATTERY TUBE ASSEMBLY NOTED. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR¿ASSEMBLY NOTED.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 MISSING DISPLAY WINDOW/COVER, A CRACKED KEYPAD OVERLAY, A KEYPAD OVERLAY PEELING, A PILLOWING KEYPAD OVERLAY, A SCRATCHED CASE, A SERIAL NUMBER LABEL FADING AND A END CAP ADDRESS LABEL MISSING. A CRACKED RETAINER WAS CONFIRMED. COSMETIC DAMAGE WAS CONFIRMED AT THE BATTERY COMPARTMENT. UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WAS NOT CONFIRMED. HOWEVER, DURING VISUAL INSPECTION FOUND CORROSION ON THE PCBA 1 AND PCBA 2. SLIGHT CORROSION WAS ALSO FOUND ON THE BATTERY TUBE 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD REPLACE BATTERY AND FAILED BATTERY ALARM. 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
    1603915 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K 00643169554931

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown