BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1781K 670G V4.11 MG

    MDR report key: 12423113 · Received September 3, 2021

    Report

    Report Number
    2032227-2021-188807
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 27, 2021
    Report Date
    February 25, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000187415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = CLEAR. CUSTOMER RETURNED INSULIN PUMP FOR ALLEGED DAMAGE TO BATTERY COMPARTMENT AND UNEXPECTED BATTERY POWER LOSS FOUND ON 08/29/2021. CONSTANT PUMP ERROR 38 ALARMS NOTED DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. DEVICE SUCCESSFULLY DOWNLOADED TO THUS. UNABLE TO PERFORM DISPLACEMENT TEST, SLEEP CURRENT TEST, AND ACTIVE CURRENT TEST DUE TO PUMP ERROR ALARMS. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE AND LOADED VOLTAGE WERE WITHIN SPECIFICATION RANGE. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND EVIDENCE OF MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY (ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2), MOTOR, AND FORCE SENSOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE), CRACKED BATTERY TUBE THREADS, CRACKED RETAINER, STAINED KEYPAD OVERLAY, CORRODED BATTERY TUBE, AND MINOR SCRATCHES ON LCD WINDOW. IN SUMMARY, CUSTOMER ALLEGATION FOR COSMETIC DAMAGE WAS CONFIRMED DURING VISUAL INSPECTION WHERE CRACKED CASE (BATTERY TUBE) WAS NOTED. UNEXPECTED BATTERY POWER LOSS WAS NOT CONFIRMED. ADDITIONALLY, PUMP ERROR 38 WAS CONFIRMED DUE TO CORRODED MOTOR HOME SWITCH. 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 NO LONGER WORKS DUE TO A CRACK IN THE MICRO WATER HAD ENTERED. 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
    1323358 PUMP MMT-1781K 670G V4.11 MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1781K HG3A2FR 000000763000187415

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown