BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12358232 · Received August 24, 2021

    Report

    Report Number
    2032227-2021-183929
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    August 15, 2021
    Report Date
    April 12, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING=BLACK CUSTOMER COMPLAINED ON 08/19/2021 THE PUMP ALARMED FAILED BATTERY TEST, PUMP ERROR 4 AND PUMP ERROR 53. UNIT PASSED ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT TEST, SELFTEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. NO BLANK DISPLAY, FAILED BATTERY TEST, PUMP ERROR 4 OR PUMP ERROR 53 NOTED DURING TEST. UNIT SUCCESSFULLY DOWNLOADED TO THUS. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. VERIFIED PUMP ALARMED FAILED BATTERY TEST ON 08/14/2021 11:21:43.000 IN PUMP DOWNLOADED HISTORY. THE FORMATTED HISTORY FILE CONFIRMED THE PUMP ALARMED PUMP ERROR 4 ON 08/14/2021 10:56:38.000 AND PUMP ERROR 53 ALARM (LINE NUMBER 5632 FILE NUMBER 2005) ON 08/14/2021 11:21:03.000 DUE TO SOFTWARE ERROR. NO MOISTURE DAMAGE NOTED TO ELECTRONIC ASSEMBLY OR MOTOR ASSEMBLY PER VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CRACKED CASE (BATTERY TUBE). THE P-CAP/RESERVOIR DOES LOCK PROPERLY. PUMP PASSED FUNCTIONAL TESTING. NO BLANK DISPLAY, FAILED BATTERY TEST, PUMP ERROR 4 OR PUMP ERROR 53 NOTED DURING TEST. HOWEVER, THE FORMATTED HISTORY FILE CONFIRMED THE PUMP ALARMED PUMP ERROR 4 ON 08/14/2021 10:56:38.000 AND PUMP ERROR 53 ALARM (LINE NUMBER 5632 FILE NUMBER 2005) ON 08/14/2021 11:21:03.000 DUE TO SOFTWARE ERROR. CONFIRMED PUMP ALARMED FAILED BATTERY TEST ON 08/14/2021 11:21:43.000 IN PUMP DOWNLOADED HISTORY. 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER REPORTED INSULIN PUMP SWITCHED OFF AND INSERTED NEW BATTERY AND RECEIVE BATTERY FAILED ALARM. CUSTOMER REPORT THAT SHE TRIED SEVERAL BATTERIES AND SAME ERRORS OCCURRED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259755 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 HG4DWX9 000000763000317119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown