BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 13378303 · Received January 27, 2022

    Report

    Report Number
    2032227-2022-106543
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Date of Event
    January 23, 2022
    Report Date
    December 10, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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.

    Additional Manufacturer Narrative · 0

    S/W VERSION 4.11E. RETAINER RING = BLACK. CASE TYPE: NGP. CUSTOMER RETURNED PUMP FOR ALLEGED BLANK DISPLAY AND UNEXPECTED BATTERY POWER LOSS OBSERVED ON (B)(6) 2022. THE PUMP PASSED THE SELF TEST, DISPLACEMENT TEST, ACTIVE CURRENT TEST, AND SLEEP CURRENT TEST. NO UNEXPECTED POWER LOSS ALARMS/ALERTS/ANOMALIES NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. THE FOLLOWING POWER ALARMS/ALERTS NOTED IN DOWNLOADED HISTORY ON EVENT DATE: LOW BATTERY ALERT [104] ON 01/22/2022 15:40:00.000, REPLACE BATTERY ALERT [73] ON 01/23/2022 01:11:00.000, REPLACE BATTERY NOW ALARM [11] ON 01/23/2022 01:42:00.000, POWER LOSS ALARM [6] ON 01/23/2022 07:33:14.000, AND BATTERY FAILED ALARM [58] ON 01/23/2022 06:57:36.000. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. THE FOLLOWING ALARMS/ALERTS WERE NOTED ON EVENT DATE: PUMP ERROR 53 ON 01/23/2022 07:16:09.000. CONFIRMED PUMP ERROR 53 (FILENUMBER = 2005 LINENUMBER = 5632) DUE TO SOFTWARE ANOMALY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR OR FORCE SENSOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: BATTERY TUBE THREADS - CRACKED, STAINED KEYPAD OVERLAY, AND PILLOWING KEYPAD OVERLAY. PUMP PASSED REQUIRED TESTING. NO BLANK DISPLAY NOTED DURING ANALYSIS, BLANK DISPLAY NOT CONFIRMED. NO UNEXPECTED POWER LOSS ALARMS/ALERTS/ANOMALIES NOTED DURING TESTING. UNEXPECTED BATTERY POWER LOSS NOT CONFIRMED. PUMP ERROR 53 CONFIRMED DUE TO SOFTWARE ANOMALY. 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 INSULIN PUMP HAD A BLANK DISPLAY AND CUSTOMER RECEIVED BATTERY FAILED ALARM. INSULIN PUMP WAS NOT TURN ON . CUSTOMER STATED THAT THE DISPLAY WAS NOT BLANK LESS THAN 30 SECONDS AND DID NOT RETURN. CUSTOMER STATED THAT THE DISPLAY DID NOT RETURN AFTER INSULIN PUMP RESTART. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572536 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG4J0YN 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female