BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 11918066 · Received June 1, 2021

    Report

    Report Number
    2032227-2021-151744
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    April 14, 2021
    Report Date
    November 7, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    0000007630002835
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER = BLACK. ON (B)(6) 2021 THE CUSTOMER ALLEGED THAT THE SENSOR IS AWFUL AND THE SENSOR DOESN'T WORK (SENSOR GLUCOSE AND BLOOD GLUCOSE) DO NOT MATCH. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, STAINED KEYPAD OVERLAY, SERIAL NUMBER LABEL FADED, AND PILLOWING KEYPAD. 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 .08675 INCHES. DEVICE WAS PROGRAMMED WITH A TEST GUARDIAN 3 LINK AND A TEST PLUG. THE PUMP COMMUNICATED PROPERLY WITH THE SENSOR AND TEST PLUG. THE DISPLAY SHOWED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. DEVICE CALIBRATED TO SEVERAL PROGRAMMED TEST VALUES PROPERLY AND DISPLAYED CORRECTLY ON THE DISPLAY GRAPH. DEVICE WAS THEN PROGRAMMED WITH TEST GLUCOSE METER. THE PUMP COMMUNICATED PROPERLY AND RECORDED THE 115 MG/DL TEST VALUE PROPERLY FROM GLUCOSE METER. PROGRAMMED A REMOTE 2-UNIT BOLUS, TRANSMITTED TO THE PUMP, AND THE PUMP DELIVERED THE BOLUS PROPERLY. THE PUMP WAS MONITORED FOR SEVERAL DAYS WHILE CONNECTED TO THE TEST TRANSMITTER AND TEST PLUG. NO UNEXPECTED BLOOD GLUCOSE METER TO INSULIN PUMP COMMUNICATION ERRORS, GLUCOSE SENSOR SIMULATOR/TRANSMITTER COMMUNICATION ERRORS, CALIBRATION ERRORS, OR ANY SENSOR RELATED ALARMS NOTED DURING TESTING. SENSOR NOT WORKING PROPERLY (SENSOR GLUCOSE AND BLOOD GLUCOSE) DO NOT MATCH COMPLAINT IS NOT CONFIRMED. NO UNEXPECTED BLOOD GLUCOSE METER TO INSULIN PUMP COMMUNICATION ERRORS, GLUCOSE SENSOR SIMULATOR/TRANSMITTER COMMUNICATION ERRORS, CALIBRATION ERRORS, OR ANY SENSOR RELATED ALARMS NOTED DURING TESTING. 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER VIA SOCIAL MEDIA THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 50 MG/DL. CUSTOMER WAS NO LONGER WEARING THE CONTINUOUS GLUCOSE MONITORING. IT WAS UNKNOWN IF THE AUTO MODE WAS ACTIVE AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810372 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG3V4JZ 0000007630002835

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Other FRN-MMT-332-RSVR, UNOMED SET, OZP-MMT-7020-SNSR| FRN-MMT-332-RSVR, UNOMED SET, OZP-MMT-7020-SNSR