BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 12554774 · Received September 30, 2021

    Report

    Report Number
    2032227-2021-200017
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    September 25, 2021
    Report Date
    April 4, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000192143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING - CLEAR. CUSTOMER RETURNED PUMP FOR A ALLEGED PUMP ERROR 23, 49, 68, 53 AND A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) FOUND ON SEP 25, 2021. UNIT PASSED DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, ACTIVE CURRENT TEST AND OCCLUSION TEST. PUMP ALARMED PUMP ERROR 75 DURING SELF TEST. PUMP DID NOT PASS SLEEP TEST DUE TO THE INTERNAL BATTERY NOT HOLDING CHARGE. TEST P-CAP WAS ABLE TO LOCK INTO THE RESERVOIR TUBE SUCCESSFULLY, HOWEVER, DAMAGED RETAINER RING NOTED. INTERNAL BATTERY WAS TESTED ON THE NGP SYSTEM BOARD, WHICH CONFIRMED THAT THE INTERNAL BATTERY DOES NOT HOLD CHARGE. UNIT SUCCESSFULLY DOWNLOADED TO THUS. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS NOT WITHIN SPEC RANGE. LOADED VOLTAGE (LOADED VLITH) WAS LESS THAN 3.7V FOR 4 CONSECUTIVE HOURS DUE TO A FAULTY INTERNAL BATTERY. PUMP ERROR 23 WAS FOUND IN THE PUMP HISTORY ON SEP 23, 2021 AT 21:35 THROUGH 22:36 DUE TO PUMP START UP AFTER RESET. PUMP ERROR 49 WAS FOUND IN THE PUMP HISTORY ON SEP 23, 2021 AT 21:33 THROUGH 22:36 DUE TO BAD HISTORY POINTERS. PUMP ERROR 68 WAS FOUND IN THE PUMP HISTORY ON SEP 23, 2021 AT 21:33 THROUGH 22:35 DUE TO A TRACE CHECK ERROR. PUMP ERROR 53 WAS FOUND IN THE PUMP HISTORY ON SEP 23, 2021 AT 21:33 (LINE NUMBER 511 FILE NUMBER 65048). PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLY AS PER GLOBAL LOGIC ANALYSIS ESF1925624. PUMP ERROR 75 ALARM WAS FOUND IN THE PUMP HISTORY ON SEP 23, 2021 AT 23:45 DUE TO A FAULTY INTERNAL BATTERY. THE ELECTRONIC ASSEMBLIES AND MOTOR ASSEMBLIES WERE INSPECTED AND NO MOISTURE OR PHYSICAL DAMAGE NOTED. THE FOLLOWING WAS NOTED BY VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, SCRATCHED CASE, CRACKED CASE (BATTERY TUBE), CRACKED CASE ON CORNER OF BELT CLIP RAILS, BROKEN BELT CLIP RAILS, CRACKED RETAINER, CRACKED KEYPAD OVERLAY, BATTERY TUBE THREADS CRACKED AND MINOR SCRATCHES ON LCD WINDOW. IN SUMMARY, CUSTOMERS ALLEGED CRITICAL PUMP ERROR WAS NOT CONFIRMED. HOWEVER, PUMP ERROR 23, 49 AND 68 WERE CONFIRMED DUE TO PUMP RESET AND PUMP ERROR 53 WAS CONFIRMED DUE TO A SOFTWARE ERROR. 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 THE INSULIN PUMP HAD OPEN BOOK IMAGE ON THE SCREEN. TROUBLESHOOTING WAS PERFORMED. MULTIPLE PUMP ERRORS WERE DISPLAYED BEFORE THE OPEN BOOK IMAGE WAS DISPLAYED ON THE SCREEN. 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
    1449262 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG34M42 000000763000192143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown