BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 17412212 · Received July 28, 2023

    Report

    Report Number
    2032227-2023-244708
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    July 10, 2023
    Report Date
    September 5, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000090203
    PMA / PMN Number
    P150001
    Removal / Correction Number
    2032227-060322-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP BOOTED UP ONCE INSTALLING AN AA BATTERY, NO BLANK DISPLAY WAS NOTED, PUMP WAS NOT RECEIVED WITH ORIGINAL BATTERY CAP. THE PUMP PASSED THE DISPLACEMENT TEST, SLEEP CURRENT TEST, AND ACTIVE CURRENT TEST. THE PUMP FAILED THE SELF TEST DUE TO APPEARANCE OF PUMP ERROR 63. TEST P-CAP LOCKED PROPERLY INTO THE RESERVOIR COMPARTMENT, HOWEVER, A CRACKED RETAINER RING WAS NOTED DURING VISUAL INSPECTION. SUCCESSFULLY DOWNLOADED PUMP HISTORY FILES AND TRACES USING THUS SOFTWARE. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. PUMP ALARMED A LOW BATTERY ALERT ON (B)(6) 2023 AT 22:11:00.000. PUMP ALARMED A REPLACE BATTERY ALERT ON THE EVENT DATE OF (B)(6) 2023 AT 07:42:00.000. PUMP ALARMED A POWER LOSS ALARM ON THE EVENT DATE OF (B)(6) 2023 AT 10:58:26.000. ALL PREVIOUSLY MENTIONED BATTERY ALERTS OR ALARMS WERE EXPECTED. PUMP ALARMED A PUMP ERROR 63 ALARM (VARIABLE #: 3)DURING TESTING ON (B)(6) 2023 AT 06:42:03.000 DUE TO BROKEN TRACES ON THE U1 CHIP AT THE KEYPAD ASSEMBLY ON PINS # 6 SDA AND #1 VDD. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, AND FORCE SENSOR. ALSO FOUND BROKEN TRACES ON THE U1 CHIP AT THE KEYPAD ASSEMBLY ON PINS # 6 SDA AND #1 VDD. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: CORRODED BATTERY TUBE, CORRODED BATTERY TUBE SPRING, SCRATCHED CASE, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, CRACKED RETAINER, PILLOWING KEYPAD OVERLAY, KEYPAD OVERLAY TEXTURE DAMAGE, AND LABEL DAMAGE. UNABLE TO VERIFY CUSTOMER'S COMPLAINT FOR BATTERY CAP CONTACT MISSING/DAMAGED. BLANK DISPLAY WAS NOT CONFIRMED DURING TESTING. RETAINER RING DAMAGE WAS CONFIRMED DURING VISUAL INSPECTION. PUMP ERROR 63 WAS CONFIRMED DURING TESTING DUE TO BROKEN TRACES ON THE U1 CHIP AT THE KEYPAD ASSEMBLY ON PINS # 6 SDA AND #1 VDD. 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 · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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. 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED A BLANK DISPLAY ON THE INSULIN PUMP AS THE BATTERY CAP CONTACTS ARE DAMAGED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND THE DISPLAY REMAINED BLANK EVEN AFTER REPLACING NEW AA BATTERIES. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND IT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920792 PUMP MMT-1780KPK 670G PATHWAY BLACK MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2E7XJ 000000763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male