BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 12458720 · Received September 13, 2021

    Report

    Report Number
    2032227-2021-191471
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    September 6, 2021
    Report Date
    March 28, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000069001
    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 PUMP FOR AN ALLEGED AUDIO/VIBRATE ANOMALY/ABSENCE OF ALARM, CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM, PUMP ERROR 53 ALARM AND FAILED BATT TEST OR BATTERY FAILED ALERT FOUND ON (B)(6) 2021. PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO VERIFY AUDIO/VIBRATE ANOMALY/ABSENCE OF ALARM AND PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. SUCCESSFULLY UTILIZED CREST AND THUS TO DOWNLOAD HISTORY FILES, TRACES AND COMLINK3 FILES. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM TRIGGERED BY THREE CONSECUTIVE PUMP ERROR 53 ALARMS ON (B)(6) 2021 12:21:58.000, (B)(6) 2021 12:22:40.000 AND (B)(6) 2021 12:23:02.000. PUMP ERROR 53 ALARM DUE TO SOFTWARE ERROR (LINENUMBER = (B)(4) ; FILENUMBER = (B)(4)). 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. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 12:20:34.000 TO (B)(6) 2021 12:23:02.000 FAILED BATT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 12:20:34.000 TO (B)(6) 2021 12:23:02.000 UPON CHECKING THE POWER DATA, FAILED BATT ALERT/BATTERY FAILED ALARM WAS EXPECTED SINCE THE BATTERY HAS LOW POWER. THE CUSTOMER MAY HAVE USED A LOW POWER BATTERY. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (22.5 MV). 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, A SCRATCHED CASE AND A SERIAL NUMBER LABEL FADING. A CRACKED RETAINER WAS CONFIRMED. UNABLE TO VERIFY AUDIO/VIBRATE ANOMALY/ABSENCE OF ALARM DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS CONFIRMED DUE TO THREE CONSECUTIVE PUMP ERROR 53 ALARMS. PUMP ERROR 53 ALARMS DUE TO SOFTWARE ERROR. FAILED BATT/BATTERY FAILED ALARM WAS NOT CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE. 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 AN AUDIO ANOMALY. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD CRITICAL PUMP ERROR AND SOFTWARE ERROR DETECTED ALARM. INSULIN PUMP HAD BATTERY FAILED ALARM. TROUBLESHOOTING WAS PERFORMED. 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
    1361442 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG29X3T 000000763000069001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown