BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 12357338 · Received August 24, 2021

    Report

    Report Number
    2032227-2021-183698
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    August 13, 2021
    Report Date
    September 22, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08660 INCHES. NO UNEXPECTED PUMP ERROR 43 ALARM NOTED DURING THE TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. THERE WAS NO PUMP ERROR 43 ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. HOWEVER, PUMP ERROR 43 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/14/2021 00:07:37.000, 08/14/2021 01:48:25.000, 08/14/2021 01:56:43.000, 08/14/2021 02:10:48.000, AND PUMP ERROR 130 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/14/2021 00:05:04.000, 08/14/2021 01:43:04.000, 08/14/2021 01:49:23.000, 08/14/2021 01:49:28.000, NO PUMP ERROR 37, 38, 39, 41, 42, 79, 80 AND 82 ALARM ON THE FORMATTED HISTORY FILE NOTED. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1, PCBA 2 AND MOTOR ASSEMBLY NOTED. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE FORCE SENSOR AND VIBRATOR ASSEMBLY NOTED. PUMP ERROR 43 ALARM AND PUMP ERROR 130 ALARM DUE TO CORROSION ON THE PCBA 1, PCBA 2 AND MOTOR ASSEMBLY. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT. HOWEVER, A CRACKED RETAINER WAS NOTED DURING TESTING. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A STAINED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. A CRACKED RETAINER WAS CONFIRMED. PUMP ERROR 43 ALARM AND PUMP ERROR 130 ALARM WERE CONFIRMED. PUMP ERROR 43 ALARM AND PUMP ERROR 130 ALARM DUE TO CORROSION ON THE PCBA 1, PCBA 2 AND MOTOR ASSEMBLY NOTED. 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD AN ERROR IN THE MOTOR WAS DETECTED BY READING UNEXPECTED VALUE FROM HALL SENSOR ALARM. CUSTOMER STATED THEY WERE UNABLE TO COMPLETE REWIND PROCESS. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM. 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
    1261008 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K A000557066 000000763000283575

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown