BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 11600801 · Received April 1, 2021

    Report

    Report Number
    2032227-2021-130015
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 26, 2021
    Report Date
    January 21, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED COSMETIC DAMAGE, BLANK DISPLAY AND FAILED BATTERY ALERT/BATTERY FAILED ALARM FOUND ON (B)(6) 2021. THE INSULIN PUMP WAS RECEIVED WITH A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. 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 HOURS AND NO BLANK DISPLAY AND FAILED BATTERY ALERT/BATTERY FAILED ALARM NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPECIFIC RANGE. NO ALARMS OR ALERTS NOTED DURING THE TESTING. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 05:39:33.000 TO (B)(6) 2021 05:42:21.000. REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 05:01:00.000 TO (B)(6) 2021 05:11:00.000. REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 05:32:00.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) /2021 05:43:26.000 TO 03/26/2021 05:43:37.000. AND FAILED BATTERY/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 05:39:43.000, (B)(6) 2021 05:40:35.000, (B)(6) 2021 05:41:25.000 AND (B)(6) 2021 05:42:15.000. UPON CHECKING ON THE DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM WAS EXPECTED SINCE THE BATTERY HAS LOW/NO POWER. THE CUSTOMER MAY HAVE USED A LOW/DEPLETED BATTERY. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRICAL BOARD 1, ELECTRICAL BOARD 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. ¿TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. FAILED BATTERY ALERT/BATTERY FAILED ALARM NOT CONFIRMED. BLANK DISPLAY NOT CONFIRMED. COSMETIC DAMAGE WAS CONFIRMED AT THE INSULIN PUMP CASE. 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 ALSO STATED THAT THE DISPLAY DID NOT RETURNED AFTER PUMP RESTART. 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
    501538 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4VKH3 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female