BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 12342156 · Received August 19, 2021

    Report

    Report Number
    2032227-2021-182701
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    August 10, 2021
    Report Date
    February 22, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169999770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = CLEAR. CUSTOMER RETURNED THE INSULIN PUMP FOR ALLEGED PUMP ERROR 63 AND 53 FOUND ON (B)(6) 2021. THE INSULIN PUMP PASSED DISPLACEMENT TEST AND SELF TEST. NO ALARM ANOMALIES NOTED DURING TESTING. INSULIN PUMP SUCCESSFULLY DOWNLOADED TO THUS. PUMP ERROR 63 VARIABLE 3 WAS NOTED IN THE HISTORY DOWNLOAD ON (B)(6) 2021 AT 9:05 DUE TO BROKEN TRACE U1 PIN6 ON KEYPAD ASSEMBLY, AS WELL AS PUMP ERROR 53 (LINE NUMBER 5284 AND FILE NUMBER 49) ON (B)(6) 2021 AT 14:22 DUE TO SOFTWARE ERROR TT 1978. TEST P-CAP LOCKED INTO THE RESERVOIR TUBE SUCCESSFULLY, HOWEVER, DAMAGE TO RETAINER RING NOTED. THE ELECTRONIC ASSEMBLIES WERE INSPECTED AND A DISCOLORED FLEX CONNECTOR ON ELECTRICAL BOARD 1 NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, SCRATCHED CASE, CRACKED RETAINER AND MINOR SCRATCHES ON LCD WINDOW. IN SUMMARY, CUSTOMERS ALLEGED PUMP ERROR 63 WAS CONFIRMED IN THE HISTORY FILES AND THROUGH VISUAL INSPECTION WHERE A BROKEN TRACE WAS FOUND ON THE U1 PIN 6 KEYPAD ASSEMBLY. PUMP ERROR 53 WAS CONFIRMED DUE TO SOFTWARE ERROR TT 1978. DISCOLORED FLEX CONNECTOR ON ELECTRICAL BOARD NOTED AFTER CUTTING OPEN INSULIN PUMP AND PERFORMING VISUAL INSPECTION. 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 A PUMP ERROR ALARM. CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER DID NOT RECEIVE REQUEST TO REWIND INSULIN PUMP. CUSTOMER STATED THAT THEY WERE GETTING THE INSULIN PUMP ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243419 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG264QY 000000643169999770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown