BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 12209103 · Received July 22, 2021

    Report

    Report Number
    2032227-2021-170880
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    July 13, 2021
    Report Date
    December 17, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000264727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK . CUSTOMER COMPLAINED ABOUT SECOND OCCURRENCE OF REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM IN LESS THAN 8 HOURS AFTER A LOW BATTERY WARNING FOUND EVENT DATE (B)(6) 2021. DEVICE PERFORM VISUAL INSPECTION AND PUMP RECEIVED WITH PILLOWING KEYPAD OVERLAY. DEVICE PASSED THE DISPLACEMENT TEST, SELF TEST, SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT. TESTED WITH A TEST P-CAP AND THE TEST P-CAP LOCKED IN PLACE PROPERLY. 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. 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. NO UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. HOWEVER, LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 09:24:04 INSERT BATTERY, (B)(6) 2021 10:06:00 AM LOW BATTERY ALERT, (B)(6) 2021 11:00:16 AM BATTERY REMOVED, (B)(6) 2021 11:10:27 AM FAILED BATTERY, (B)(6) 2021 11:10:37 AM BATTERY REMOVED, (B)(6) 2021 11:49:48 AM FAILED BATTERY, (B)(6) 2021 11:55:21 AM BATTERY REMOVED,(B)(6) 2021 12:09:15 PM POWER LOSS ALARM. UPON CHECKING ON THE DETAIL TRACE FILE, LOW BATTERY ALERT WAS EXPECTED SINCE THE BATTERY HAS LOW POWER. UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM NOT CONFIRMED. (B)(4). 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 SECOND OCCURRENCE OF REPLACE BATTERY NOW ALARM WITHOUT LOW BATTERY ALARM. CUSTOMER DID NOT RECEIVED A LOW BATTERY ALERT PRIOR TO THE REPLACE BATTERY ALERT. 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
    1110975 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG489U4 000000763000264727

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown