BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12287165 · Received August 6, 2021

    Report

    Report Number
    2032227-2021-177555
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 27, 2021
    Report Date
    February 4, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER = BLACK. CUSTOMER RETURNED THE INSULIN PUMP FOR AN ALLEGED UNEXPLAINED INSULIN FLOW BLOCKED ALARMS, CRACK ON THE INSULIN PUMP, UNRESPONSIVE KEYPAD, AND TRANSMITTER NOT TURNING ON FOUND ON (B)(6) 2021. THE INSULIN PUMP PASSED THE SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, AND THE DISPLACEMENT TEST. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUS. THE INSULIN FLOW BLOCKED ALARM FUNCTIONED PROPERLY DURING THE BASIC OCCLUSION, OCCLUSION, AND FORCE SENSOR TESTS. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. A REVIEW OF THE HISTORY FILES SHOWS ZERO (0) NO DELIVERY (INSULIN FLOW BLOCKED) ALARMS ON OR AROUND THE EVENT DATE (B)(6) 2021. THE HISTORY DOES SHOW THREE (3) NO DELIVERY (INSULIN FLOW BLOCKED) ALARMS ON (B)(6) 2021 AT 03:06 AND 03:12, ONE (1) NO DELIVERY (INSULIN FLOW BLOCKED) ALARM ON (B)(6) 2021 AT 08:07, AND ONE (1) NO DELIVERY (INSULIN FLOW BLOCKED) ALARM (B)(6) 2021 AT 03:44. THE INSULIN PUMP WAS PROGRAMMED WITH A GUARDIAN LINK 3 TRANSMITTER AND TEST PLUG. THE INSULIN PUMP CALIBRATED TO THE PROGRAMMED TEST VALUES PROPERLY AND DISPLAYED CORRECTLY ON THE DISPLAY GRAPH. THE PUMP WAS MONITORED FOR TWO (2) DAYS WHILE CONNECTED TO THE TRANSMITTER AND A TEST PLUG AND NO UNEXPECTED PUMP TO TRANSMITTER COMMUNICATION ERRORS, OR ADDITIONAL SENSOR RELATED ERRORS NOTED. ALL BUTTONS FUNCTIONED PROPERLY DURING TESTING. THE INSULIN PUMP WAS CUT OPEN FOR VISUAL INSPECTION. NO DAMAGE OR MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY (ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2), THE MOTOR, THE FORCE SENSOR, AND KEYPAD ASSEMBLY NOTED. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING PHYSICAL INSPECTION: SCRATCHED CASE, STAINED KEYPAD OVERLAY, AND PILLOWING KEYPAD OVERLAY. UNRESPONSIVE KEYPAD AND INSULIN FLOW BLOCKED ALARM COMPLAINT ARE NOT CONFIRMED. THE INSULIN FLOW BLOCKED ALARM FUNCTIONED PROPERLY DURING THE BASIC OCCLUSION, OCCLUSION, AND FORCE SENSOR TESTS. ALL BUTTONS FUNCTIONED PROPERLY AND NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. COSMETIC DAMAGE ON THE PUMP CASE (CRACK) WAS NOT CONFIRMED, HOWEVER, OTHER COSMETIC DAMAGE WAS NOTED. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE. THE INSULIN PUMP HAD CRACK ON CASING. INSULIN PUMP HAD RECEIVED UNEXPLAINED NO INSULIN DELIVERY ALARMS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188988 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG43TQS 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female