BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 9936688 · Received April 8, 2020

    Report

    Report Number
    3004209178-2020-95863
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 22, 2020
    Report Date
    April 6, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00763000068998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = CLEAR. CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED COSMETIC LOCATED AT THE BELT CLIP, PUMP ERROR 63 ALARM AND WAS HOSPITALIZED FOR HIGH BGS AND DKA FOUND ON MARCH, 22, 2020. ALSO, ON (B)(4), SVN#: 000311079272 - CUSTOMER RETURNED PUMP FOR AN ALLEGED POSSIBLE UNDER DELIVERY, PUMP ERROR 63 ALARM AND WAS HOSPITALIZED FOR HIGH BGS AND DKA FOUND ON (B)(6)2020. UNABLE TO CONFIRM BELT CLIP DAMAGE DUE TO INSULIN PUMP RECEIVED WITHOUT THE ORIGINAL BELT CLIP. DEVICE PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DELIVERY ACCURACY TEST AT 0.08670 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF MARCH 22, 2020, THERE IS NO UNEXPECTED ALARMS/SUSPENDS AND FOUND BOLUS WIZARD DELIVERIES OF DAILYTOTALOFBOLUSINSULINDELIVERED = 36.6 U BOLUS. 03/22/2020 08:19:34.000 NORMALBOLUSDELIVERED, NORMALBOLUSAMOUNTPROGRAMMED = 8.4, BOLUSAMOUNTDELIVERED = 8.4. 03/22/2020 11:31:42.000 NORMALBOLUSDELIVERED, NORMALBOLUSAMOUNTPROGRAMMED = 3.6, BOLUSAMOUNTDELIVERED = 3.6. 03/22/2020 13:46:04.000 NORMALBOLUSDELIVERED, NORMALBOLUSAMOUNTPROGRAMMED = 14.7, BOLUSAMOUNTDELIVERED = 14.7. 03/22/2020 23:10:56.000 NORMALBOLUSDELIVERED, NORMALBOLUSAMOUNTPROGRAMMED = 9.9, BOLUSAMOUNTDELIVERED = 9.9. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF APRIL 02, 2020, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. AS PER THE RECORD IN THE FORMATTED HISTORY FILE, DAILYTOTALCOLLECTIONSTARTTIME = 04/02/2020 15:24:33.000, THE PUMP HAD A BOLUS WIZARD DELIVERIES OF DAILYTOTALOFBOLUSINSULINDELIVERED = 13.1 U BOLUS 04/02/2020 07:58:38.000 NORMALBOLUSDELIVERED, NORMALBOLUSAMOUNTPROGRAMMED = 5.7, BOLUSAMOUNTDELIVERED = 5.7. 04/02/2020 12:01:12.000 NORMALBOLUSDELIVERED, NORMALBOLUSAMOUNTPROGRAMMED = 5.2, BOLUSAMOUNTDELIVERED = 5.2. 04/02/2020 15:44:48.000 NORMALBOLUSDELIVERED, NORMALBOLUSAMOUNTPROGRAMMED = 3.5, BOLUSAMOUNTDELIVERED = 3.5. 04/02/2020 16:15:34.000 NORMALBOLUSDELIVERED, NORMALBOLUSAMOUNTPROGRAMMED = 2.3, BOLUSAMOUNTDELIVERED = 2.3. 04/02/2020 17:04:30.000 NORMALBOLUSDELIVERED, NORMALBOLUSAMOUNTPROGRAMMED = 2.7, BOLUSAMOUNTDELIVERED = 2.7. 04/02/2020 18:21:52.000 NORMALBOLUSDELIVERED, NORMALBOLUSAMOUNTPROGRAMMED = 4.6, BOLUSAMOUNTDELIVERED = 4.6. DEVICE WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED DURING TESTING. THE KEYPAD OVERLAY WAS REMOVED TO PERFORM VISUAL INSPECTION AND FOUND A BROKEN TRACE ON U1 KEYPAD ASSEMBLY. PUMP ERROR 63 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY ON 04/02/2020 15:23:08.000 AND 04/09/2020 11:35:58.000. DEVICE 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. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (24.0 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. 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 CRACKED RETAINER, A SCRATCHED CASE AND A SERIAL NUMBER LABEL FADING. A CRACKED RETAINER WAS CONFIRMED. UNABLE TO CONFIRM BELT CLIP DAMAGE DUE TO PUMP RECEIVED WITHOUT THE ORIGINAL BELT CLIP. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS AND DKA. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. CUSTOMER ALLEGED FOR POSSIBLE UNDER DELIVERY WAS NOT CONFIRMED. HOWEVER, PUMP ERROR 63 ALARM WAS CONFIRMED. PUMP ERROR 63 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE DUE TO BROKEN TRACE ON U1 KEYPAD ASSEMBLY. 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 HAD HARDWARE LOW LEVEL FAILURE ALARM AFTER THE SELF TEST. THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND BLOOD GLUCOSE READING WAS 30 MMOL/L. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404188 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K HG2HS5R 00763000068998

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown