BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 7904946 · Received September 25, 2018

    Report

    Report Number
    2032227-2018-32990
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    September 9, 2018
    Report Date
    September 2, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00763000069001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST AND ACTIVE CURRENT MEASUREMENT. HOWEVER, PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. ALSO, PUMP ERROR 75 ALARM, PUMP ERROR 23 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 68 ALARM DURING SELF TEST. THE PUMP WAS MONITORED FOR SEVERAL HOURS, AND NO PUMP ERROR 25 ALARM NOTED DURING THE TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE PUMP TRACE DOWNLOAD ANALYSIS CONFIRMED THE PUMP ALARMED PUMP ERROR 25, PUMP ERROR 75 ALARM, PUMP ERROR 23 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 68 ALARM. NO POWER ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. HOWEVER, PUMP ERROR 75 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/08/2018 19:50:23.000, 09/08/2018 23:08:27.000, 09/09/2018 17:21:23.000 AND 08/16/2022 13:11:07.000. AND PUMP ERROR 25 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/09/2018 03:00:00.000, 09/09/2018 03:08:00.000, 09/09/2018 07:00:00.000, 09/09/2018 07:10:00.000, 09/09/2018 11:00:00.000, 09/09/2018 11:08:00.000, 08/15/2022 13:00:00.000, 08/15/2022 13:10:00.000, 08/15/2022 17:00:00.000, 08/16/2022 09:00:00.000, 08/16/2022 09:10:00.000, 08/16/2022 13:00:00.000, 08/16/2022 13:10:00.000. PUMP ERROR 68 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/09/2018 13:10:57.000, 09/09/2018 17:05:18.000, 09/09/2018 17:25:28.000. PUMP ERROR 49 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/09/2018 13:10:57.000, 09/09/2018 13:11:19.000, 09/09/2018 17:05:18.000, 09/09/2018 17:05:49.000, 09/09/2018 17:25:28.000, 09/09/2018 17:25:43.000. PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/09/2018 13:11:34.000, 09/09/2018 17:06:08.000, 09/09/2018 17:26:01.000. THE POWER MANAGEMENT TOOL CONFIRMED PUMP ERROR 25 ALARM, PUMP ERROR 75 ALARM PUMP ERROR 23 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 68 ALARM DURING SELF TEST AND HIGH SLEEP CURRENT MEASUREMENT DUE TO CONNECTOR RESISTANCE (J6 PCB 1). THE LOADED VOLTAGE (LOADED VLITH) AND THE UNLOADED VOLTAGE (UNLOADED VLITH) DISPLAY AT THE POWER GRAPH MANAGEMENT TOOL SHOWS ABNORMAL BEHAVIOR. AFTER DISCONNECTING AND RECONNECTING THE INTERNAL BATTERY CONNECTOR ON J6 PCBA 1, PUMP WAS MONITORED AND FUNCTIONED PROPERLY. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA1, PCBA2, FORCE SENSOR AND MOTOR ASSEMBLY NOTED. NO CORROSION OR MOISURE DAMAGE FOUND ON THE 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 PILLOWING KEYPAD OVERLAY, A CRACKED RETAINER AND A SCRATCHED CASE. A CRACKED RETAINER WAS CONFIRMED. PUMP ERROR 25 ALARM, PUMP ERROR 75 ALARM PUMP ERROR 23 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 68 ALARM WERE CONFIRMED. PUMP ERROR 25 ALARM, PUMP ERROR 75 ALARM PUMP ERROR 23 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 68 ALARM DUE TO CONNECTOR RESISTANCE ISSUE ON J6/PCB1. HOWEVER, DURING VISUAL INSPECTION FOUND CORROSION ON THE PCBA1, PCBA2, FORCE SENSOR AND MOTOR 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.

    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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEIR INSULIN PUMP HAD A POWER ERROR DETECTED ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748836 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG2764T 00763000069001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown