BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12497347 · Received September 20, 2021

    Report

    Report Number
    2032227-2021-195611
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    September 14, 2021
    Report Date
    April 5, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER RETURNED PUMP FOR AN ALLEGED STUCK BUTTON ALARM, UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND E/A ALARM FOUND ON SEPT 14, 2021. THE PUMP WAS RECEIVED WITH NO BUTTON RESPONSE. UNABLE TO PERFORM THE FUNCTIONAL TESTS, 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, KEYPAD VOLTAGE TEST AND DAT DUE TO NO BUTTON RESPONSE. UNABLE TO DOWNLOAD HISTORY FILES AND TRACES USING THUS DUE TO NO BUTTON RESPONSE. UNABLE TO GENERATE POWER MANAGEMENT GRAPH DUE TO NO BUTTON RESPONSE. THE KEYPAD OVERLAY WAS PEELED OFF AND FOUND A CORRODED KEYPAD TRACES. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. BY USING A TEST CASE, THE PUMP WAS ABLE TO NAVIGATE THE MENU AND CONTINUED TESTING AND DOWNLOAD. THE PUMP PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. NO KEYPAD ANOMALY NOTED WHEN USING THE TEST CASE. IN CONCLUSION, THE PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. PUMP ERROR 61 (STUCK KEY ALARM) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON THE EVENT DATE: 09/14/2021 01:45:16.000, 09/14/2021 01:45:16.000, 09/14/2021 01:59:14.000, 09/14/2021 02:17:14.000 AND 09/14/2021 02:36:14.000 DUE TO CORRODED KEYPAD TRACES. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS OR ALERTS NOTED DURING THE TESTING. NO UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/14/2021 01:57:07.000 TO 09/14/2021 04:24:26.000. FAILED BATT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/14/2021 01:57:24.000 TO 09/14/2021 02:24:00.000. AND POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/14/2021 04:35:27.000 AND 09/14/2021 04:35:38.000. UPON CHECKING ON THE POWER DATA, FAILED BATT/BATTERY FAILED ALARM AND POWER LOSS ALARM WAS EXPECTED SINCE THE BATTERY HAS LOW/NO POWER. THE CUSTOMER MAY HAVE USED A LOW/DEPLETED BATTERY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. KEYPAD UNRESPONSIVE/STUCK BUTTON ALARM/PUMP ERROR 61 ALARM WAS CONFIRMED DUE TO CORRODED KEYPAD TRACES. HOWEVER, BY USING A TEST CASE, THE PUMP WAS ABLE TO NAVIGATE THE MENU AND CONTINUED TESTING AND DOWNLOAD. UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WAS NOT CONFIRMED. 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 HAD MULTIPLE PUMP ERROR ALARMS. CUSTOMER REPORTED KEYPAD ANOMALY AND THEY RECEIVED STUCK BUTTON ALARM. CUSTOMER STATED THAT A BUTTON WAS CONTINUALLY PRESSED FOR MORE THAN 3 MINUTES. CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARM AND BUTTONS WERE RESPONDING NOW. CUSTOMER WAS CALLING BACK WITH POWER LOSS ALARM AFTER LEAVING CURRENT BATTERY IN PUMP FOR 1 HOUR. CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARM AND WERE ABLE TO REWIND INSULIN PUMP. FILL CANNULA WAS NOT RECORDED IN DAILY HISTORY. 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
    1400151 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG46Z24 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female