BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 12802060 · Received November 12, 2021

    Report

    Report Number
    2032227-2021-217574
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    November 7, 2021
    Report Date
    May 6, 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

    (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 INSULIN PUMP, WHICH IS NOT MARKETED IN THE INSULIN PUMPED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION INSULIN PUMP, WHICH IS MARKETED IN THE INSULIN PUMPED STATES.

    Additional Manufacturer Narrative · 0

    UNIT PASSED DISPLACEMENT TEST AND SELF TEST AND P-CAP/RESERVOIR DOES LOCK PROPERLY, HOWEVER, DAMAGE TO THE RETAINER RING WAS NOTED DURING VISUAL INSPECTION. HISTORY/TRACE DOWNLOADS WERE SUCCESSFUL USING THUS SOFTWARE. PUMP TRACE DOWNLOAD CONFIRMED THE PUMP ALARMED PUMP ERROR 63 VARIABLE 03 ON (B)(6) 2021 00:37:52.000 DUE TO BROKEN TRACE U1 PIN6 ON KEYPAD ASSEMBLY. PUMP ERROR 54 (FILE NUMBER = 32122, LINE NUMBER = 1421) WAS PRESENT IN THE HISTORY DOWNLOAD ON EVENT DATE OF (B)(6) 2021 00:00:11.000, ESF#: ESF (B)(4). PUMP ERROR 3 CONFIRMED ON (B)(6) 2021 00:00:13.000 IN CONSEQUENCE OF PUMP ERROR 54. THE ELECTRONIC ASSEMBLIES WERE INSPECTED AND NO ANOMALIES NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, KEYPAD OVERLAY TEXTURE DAMAGE, OVERLAY SCRATCHED, SCRATCHED CASE, DAMAGED DISPLAY WINDOW COVER, LABEL DAMAGE (STAINED/TORN SERIAL NUMBER LABEL), BROKEN TRACE AND CRACKED RETAINER. NO MOISTURE DAMAGE NOTED ON PCB1/PCB2 NOTED UPON VISUAL INSPECTION OF COMPONENTS. PUMP TRACE DOWNLOAD CONFIRMED THE PUMP ALARMED PUMP ERROR 63 VARIABLE 03 ON (B)(6) 2021 00:37:52.000 CONFIRMED DUE TO BROKEN TRACE U1 PIN6 ON KEYPAD ASSEMBLY. PUMP ERROR 3, CONFIRMED ON (B)(6) 2021 00:00:13.000, PROCEEDING PUMP ERROR 54, (FILE NUMBER = 32122, LINE NUMBER = 1421) ESF#: ESF(B)(4) , CONFIRMED DUE TO 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MULTIPLE PUMP ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM BUT DID NOT RECEIVED REQUEST TO REWIND INSULIN PUMP. 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
    1706238 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG3MB2Q 000000763000192143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown