BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1781K 670G V4.11 MG

    MDR report key: 13390984 · Received January 31, 2022

    Report

    Report Number
    2032227-2022-107060
    Event Type
    Malfunction
    Date Received
    January 31, 2022
    Date of Event
    January 26, 2022
    Report Date
    November 21, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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.

    Additional Manufacturer Narrative · 0

    RETAINER RING = MISSING CUSTOMER RETURNED DEVICE FOR AN ALLEGED POST-RESET RAM CRC ALARM FOUND ON (B)(6) 2022.DEVICE WAS RECEIVED WITH THE ORIGINAL BATTERY STUCK AND CORRODED IN THE BATTERY COMPARTMENT. DEVICE WAS RECEIVED WITH A MISSING RESERVOIR TUBE O-RING AND A MISSING RETAINER. UNABLE TO PERFORM SELF TEST AND DISPLACEMENT TEST DUE TO THE ORIGINAL BATTERY STUCK AND CORRODED IN THE BATTERY COMPARTMENT. UNABLE TO DOWNLOAD HISTORY FILES AND TRACES USING THUS DUE TO THE ORIGINAL BATTERY STUCK AND CORRODED IN THE BATTERY COMPARTMENT. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRIC BOARD , FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. A TEST CASE WAS USED AND THE ORIGINAL ELECTRIC BOARD, INTERNAL BATTERY AND MOTOR WERE INSTALLED. POWERED THE DEVICE ON USING THE AA 1.5VOLT BATTERY, CONTINUED SELF TEST AND DOWNLOAD. THE DEVICE PASSED THE SELF TEST. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. THERE IS NO POST-RESET RAM CRC ALARM RECORDED AND FOUND IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. HOWEVER, POST-RESET RAM CRC ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2022 17:01:07.000. PUMP ERROR 58 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2022 16:58:37.000, (B)(6) 2022 16:58:50.000, (B)(6) 2022 16:59:15.000 (B)(6)2022 16:59:36.000, (B)(6)17:07:42.000, 17:08:07.000 (B)(6) 2022 11:31:47.000POST-RESET RAM CRC ALARM WAS EXPECTED SINCE THE BATTERY INSERTED ON A BATTERY CHANGE DOES NOT HAVE SUFFICIENT VOLTAGE. DEVICE WAS MONITORED WITHOUT THE TEST ENERGIZER BATTERY INSIDE THE BATTERY COMPARTMENT AND REINSERTS IT BACK INTO THE BATTERY COMPARTMENT FOR LESS THAN 10 MINUTES AND NO UNEXPECTED POST-RESET RAM CRC ALARM ALARM NOTED. UNABLE TO LOCK A TEST P-CAP INTO THE RESERVOIR COMPARTMENT DUE TO A MISSING RESERVOIR TUBE O-RING AND A MISSING RETAINER. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A KEYPAD OVERLAY TEXTURE DAMAGE AND A SCRATCHED CASE. A MISSING RESERVOIR TUBE O-RING AND A MISSING RETAINER WERE CONFIRMED. UNABLE TO DOWNLOAD HISTORY FILES AND TRACES USING THUS DUE TO THE ORIGINAL BATTERY STUCK AND CORRODED IN THE BATTERY COMPARTMENT. THE ORIGINAL BATTERY STUCK AND CORRODED IN THE BATTERY COMPARTMENT WAS CONFIRMED DUE TO CORROSION ON THE BATTERY TUBE. HOWEVER, A TEST CASE WAS USED CONTINUED SELF TEST AND DOWNLOAD. POST-RESET RAM CRC ALARM WAS NOT CONFIRMED. 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PUMP ERROR ALARM. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE UNABLE TO REWIND THE INSULIN PUMP. 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
    1622561 PUMP MMT-1781K 670G V4.11 MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1781K HG3S22Y 000000763000283544

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown