BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1714K 630G BLACK MMOL CANADA

    MDR report key: 12318291 · Received August 13, 2021

    Report

    Report Number
    2032227-2021-180396
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    August 2, 2021
    Report Date
    January 31, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000643169782396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER =¿CLEAR CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM/MOISTURE DAMAGE/BLANK DISPLAY FOUND ON (B)(6) 2021. NO¿CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM/BLANK DISPLAY¿NOTED AFTER BATTERY INSERTION. DEVICE WAS RECEIVED WITH A MISSING SEGMENTS/PARTIAL DISPLAY. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST, SELF TEST DUE TO MISSING SEGMENTS/PARTIAL DISPLAY.¿SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE¿ON THE ELECTRICAL BOARD 1 / ELECTRICAL BOARD 2 / FORCE SENSOR. PUMP ERROR 3 FATAL ALARM CONFIRMED IN THE HISTORY FILES ON (B)(6) 2021 AT 9:08 PM DUE TO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY.¿FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING.¿THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION:¿CRACKED BATTERY TUBE THREADS, CRACKED CASE AT CORNER OF THE BELT CLIP RAILS AND CRACKED CASE ALONG THE SIDE OF THE BATTERY TUBE. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM/BLANK DISPLAY¿NOT CONFIRMED.¿¿EXPOSED TO MOISTURE WAS CONFIRMED. PUMP ERROR 3 ALARM/MISSING SEGMENTS/PARTIAL DISPLAY DUE TO MOISTURE DAMAGE ELECTRONIC ASSEMBLY. COSMETIC DAMAGE FOUND ON THE BACK OF THE INSULIN 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 · 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 SHOWED CRITICAL PUMP ERROR AFTER CUSTOMER FELL INTO THE POOL. CUSTOMER STATED INSULIN PUMP STOPPED ALARMING AND TURNED OFF. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219007 PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1714K HG2JZRP 000000643169782396

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown