BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 16167192 · Received January 14, 2023

    Report

    Report Number
    2032227-2023-113430
    Event Type
    Malfunction
    Date Received
    January 14, 2023
    Date of Event
    March 1, 2022
    Report Date
    June 14, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169999770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP WAS RECEIVED WITH A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. THE PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08710 INCHES. THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. THERE WAS ¿NO¿ NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. HOWEVER, NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS FOUND IN THE FORMATTED HISTORY FILE ON: NO DELIVERY (7) 02/24/2022 08:37:22.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/24/2022 08:37:50.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/24/2022 08:38:08.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/24/2022 08:38:26.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/24/2022 08:38:48.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/24/2022 20:25:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/24/2022 20:25:22.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/24/2022 20:25:42.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/24/2022 20:26:01.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/24/2022 20:26:23.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/24/2022 20:26:41.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/24/2022 20:26:59.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/25/2022 08:38:35.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/25/2022 08:38:55.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/25/2022 08:39:14.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/25/2022 08:39:35.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/25/2022 08:39:55.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/25/2022 20:05:04.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/26/2022 20:12:02.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/26/2022 20:12:46.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 02/26/2022 20:13:06.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 01-MAR-2022 IN THE FORMATTED HISTORY FILE.  LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/28/2022 19:58:00.000. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/28/2022 19:59:22.000. 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/ALERTS WERE NOTED. NO POWER ERROR 25, POWER LOSS ALARM AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM NOTED 1 WEEK PRIOR TO THE EVENT DATE 01-MAR-2022 IN THE FORMATTED HISTORY FILE.  INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT WAS EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER. THE CUSTOMER MAY HAVE USED A LOW POWER BATTERY. 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 AND A SCRATCHED CASE. RETAINER RING DAMAGE (A CRACKED RETAINER) WAS CONFIRMED. COSMETIC DAMAGE WAS CONFIRMED AT THE PUMP CASE. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS NOT CONFIRMED. 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 · 0

    (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. 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

    MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC), NO DELIVERY/OCCLUSION ALARM - UNKNOWN TIMING OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303932 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG324MJ 000000643169999770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown