BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 12472689 · Received September 15, 2021

    Report

    Report Number
    2032227-2021-192613
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    September 8, 2021
    Report Date
    March 9, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED FAILED BATTERY ALERT/BATTERY FAILED ALARM AND PUMP ERROR 53 ALARM FOUND ON (B)(6) 2021. ALSO, ON CASE(B)(4), SVN#: (B)(6)- CUSTOMER RETURNED PUMP FOR AN ALLEGED PUMP ERROR 53 ALARM AND PUMP ERROR 4 ALARM FOUND ON (B)(6) 2021. THE INSULIN PUMP PASSED THE SELF TEST, DISPLACEMENT TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. DEVICE WAS MONITORED FOR SEVERAL HOURS AND FAILED BATTERY ALERT/BATTERY FAILED ALARM NOTED. NO UNEXPECTED PUMP ERROR 53 ALARM AND PUMP ERROR 4 ALARM NOTED DURING THE TESTING. 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 SPECIFICATION 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 17:26:35.000 08/23/2021 17:01:04.000 09/08/2021 12:01:30.000 AND 09/08/2021 12:01:30.000 AND FAILED BATT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 12:00:16.000, 09/08/2021 12:01:23.000, 09/08/2021 12:01:39.000 AND 09/08/2021 12:01:47.000. UPON CHECKING ON THE DETAIL TRACE FILE, FAILED BATT/BATTERY FAILED ALARM WAS EXPECTED SINCE THE BATTERY HAS LOW POWER. PUMP ERROR 4 ALARM AND PUMP ERROR 53 ALARM WERE RECORDED AND FOUND ON THE FORMATTED HISTORY FILE ON (B)(6) 2021 17:00:11.000, (B)(6) 2021 17:00:13.000, 09/08/2021 12:00:11.000, (B)(6) 2021 12:00:13.000 AND (B)(6) 2021 12:02:09.000. PUMP ERROR 4 ALARM AND PUMP ERROR 53 ALARM WERE DUE TO HARDWARE AND SOFTWARE ERROR. DEVICE 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. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS NOT CONFIRMED. PUMP ERROR 4 ALARM AND PUMP ERROR 53 ALARM WERE CONFIRMED. PUMP ERROR 4 ALARM AND PUMP ERROR 53 ALARM WERE DUE TO HARDWARE AND SOFTWARE ERROR. 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 RECEIVED SOFTWARE ERROR DETECTED ALARM AND BATTERY FAILED ALARM. 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
    1375705 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG56MGA 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female