BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12412201 · Received September 2, 2021

    Report

    Report Number
    2032227-2021-187600
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    August 24, 2021
    Report Date
    December 31, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED BLANK DISPLAY FOUND ON AUG 24, 2021. THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST. THE INSULIN PUMP WAS MONITORED FOR SEVERAL DAYS AND NO BLANK DISPLAY NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE AND LOADED VOLTAGE WERE WITHIN SPECIFICATION RANGE. NO ALARMS/ALERTS WERE FOUND IN THE HISTORY FILES OR TRACES FOR THE EVENT DATE. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/23/2021 07:58:03.000 , 08/23/2021 08:37:00.000 . LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/23/2021 00:39:00.000 , 08/23/2021 08:03:00.000 . REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/23/2021 10:41:00.000 , 08/23/2021 10:51:00.000 . REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/23/2021 10:10:00.000 , 08/23/2021 10:20:00.000 . POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/23/2021 10:52:34.000 , 08/23/2021 08:38:30.000 . UPON CHECKING ON THE DETAIL TRACE FILE, LOW BATTERY ALERT, UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM WAS EXPECTED SINCE THE BATTERY HAS LOW POWER. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR OR FORCE SENSOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A PILLOWING KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. BLANK DISPLAY 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. 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP WERE NEITHER MISSING NOR DAMAGED. CUSTOMER STATED BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THE SPRING WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THAT THE DISPLAY DID NOT RETURNED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316192 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG40CNX 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male