BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 12717126 · Received October 29, 2021

    Report

    Report Number
    2032227-2021-211881
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    October 21, 2021
    Report Date
    April 27, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER = BLACK. THE CUSTOMER ALLEGED THE PUMP IS OVER DELIVERING CAUSING LOW BGS ON 10/21/2021. THE PUMP PASSED ALL FUNCTIONAL TESTING 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 THE DAT TEST AT .08715 INCHES. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. NO OVER DELIVERY ANOMALY NOTED DURING TESTING. THE PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. NO DAMAGE OR MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2), MOTOR, OR FORCE SENSOR. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING PHYSICAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE PUMP PASSED ALL FUNCTIONAL TESTING. LOW BG AND OVER DELIVERY ANOMALIES ARE NOT CONFIRMED. THE FORMATTED HISTORY FILE LIST THE FOLLOWING MANUAL PROGRAMMED BOLUS DELIVERIES FOR 10/21/2021 10/21/2021 07:54 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 1.2 BOLUSAMOUNTDELIVERED = 1.2 10/21/2021 08:01 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.3 BOLUSAMOUNTDELIVERED = 0.3 10/21/2021 08:11 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.3 BOLUSAMOUNTDELIVERED = 0.3 10/21/2021 08:15 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.1 BOLUSAMOUNTDELIVERED = 0.1 10/21/2021 08:19 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.1 BOLUSAMOUNTDELIVERED = 0.1 10/21/2021 08:25 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.1 BOLUSAMOUNTDELIVERED = 0.1 10/21/2021 12:03 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 3.3 BOLUSAMOUNTDELIVERED = 3.3 10/21/2021 13:24 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.3 BOLUSAMOUNTDELIVERED = 0.3 10/21/2021 13:35 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.2 BOLUSAMOUNTDELIVERED = 0.2 10/21/2021 13:44 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.2 BOLUSAMOUNTDELIVERED = 0.2 10/21/2021 13:58 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.8 BOLUSAMOUNTDELIVERED = 0.8 10/21/2021 14:24 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.3 BOLUSAMOUNTDELIVERED = 0.3 10/21/2021 15:15 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.7 BOLUSAMOUNTDELIVERED = 0.7 10/21/2021 15:30 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.5 BOLUSAMOUNTDELIVERED = 0.5 10/21/2021 15:39 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.2 BOLUSAMOUNTDELIVERED = 0.2 10/21/2021 18:26 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.5 BOLUSAMOUNTDELIVERED = 0.5 10/21/2021 18:36 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 1.0 BOLUSAMOUNTDELIVERED = 1.0 10/21/2021 18:42 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.1 BOLUSAMOUNTDELIVERED = 0.1 10/21/2021 18:50 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.1 BOLUSAMOUNTDELIVERED = 0.1 10/21/2021 18:59 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.3 BOLUSAMOUNTDELIVERED = 0.3 10/21/2021 19:02 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.1 BOLUSAMOUNTDELIVERED = 0.1 10/21/2021 19:09 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.2 BOLUSAMOUNTDELIVERED = 0.2 10/21/2021 19:18 CL1 BG CORRECTION NORMALBOLUSAMOUNTPROGRAMMED = 0.1 BOLUSAMOUNTDELIVERED = 0.1. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THE USER EXPERIENCED A LOW BLOOD GLUCOSE OF 70 MG/DL. THE USER ALLEGED THE INSULIN PUMP WAS OVER DELIVERING INSULIN BECAUSE HER BLOOD GLUCOSE DROPPED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP AND RESERVOIR WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615781 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG5K7GW 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female