BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1781KL 670G MG RPL

    MDR report key: 13007826 · Received December 15, 2021

    Report

    Report Number
    2032227-2021-230476
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    December 9, 2021
    Report Date
    June 16, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED PUMP ERROR 53/68/49/23 ALARM/FAILED BATTERY TEST ALARM FOUND ON DEC 09, 2021. DEVICE PASSED THE DISPLACEMENT TEST, ACTIVE CURRENT TEST, SLEEP CURRENT TEST AND SELF TEST. NO PUMP ERROR 53/68/49/23 ALARM/FAILED BATTERY TEST ALARM NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. PUMP ERROR 53 ALARM ON DEC 09, 2021 AT 4:36. PUMP ERROR 53 ALARM DUE TO SOFTWARE ERROR (LINE NUMBER 5632 FILE NUMBER 2005), (6) PUMP ERROR 49 ALARMS FOUND IN THE PUMP HISTORY FILE/TRACE ON DEC 09, 2021 STARTED FROM 4:36 TO 4:37, (4) PUMP ERROR 68 ALARMS ON DEC 09, 2021 AT 4:36:15, 4:36:21, 4:36:38 AND 4:36:48 AND (2) PUMP ERROR 23 ALARMS AT 4:37:09 AND 4:37:18 AND (2) PUMP ERROR 58 ALARMS ON DEC 09, 2021 AT 4:36:06 AND 4:36:12. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR OR FORCE SENSOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MISSING SERIAL NUMBER LABEL, BROKEN BELT CLIP RAILS AND CRACKED SELECT BUTTON KEYPAD OVERLAY. PUMP ERROR 68/49/23 ALARM/FAILED BATTERY TEST ALARM CONFIRMED. UNABLE TO DETERMINE THE ROOT CAUSE, PROBLEM ISOLATED TO ELECTRONIC ASSEMBLY. PUMP ERROR 53 ALARM DUE TO SOFTWARE ERROR. COSMETIC DAMAGE FOUND ON THE PUMP CASE. 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 · 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. 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 · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PUMP ERROR ALARM. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP BUT ERROR WAS RECEIVED BEFORE BATTERY CHANGE. 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
    1913394 PUMP MMT-1781KL 670G MG RPL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1781KL HG4GJL3 000000763000283568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown