BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12194621 · Received July 20, 2021

    Report

    Report Number
    2032227-2021-169662
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    July 11, 2021
    Report Date
    October 26, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000190460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = CLEAR CUSTOMER CONCERN: SHE WENT TO THE WATER PARK AND SHOWER WITH IT NO CRACK ON THE PUMP CRITICAL PUMP ERROR ON (B)(6) 2021. DEVICE P-CAP OR TEST RESERVOIR LOCKS IN PLACE PROPERLY. DEVICE WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) DUE TO MOISTURE DAMAGE ON STACK ASSEMBLY PCBA1 AND PCBA2. ATTEMPTED TO DOWNLOAD USING CREST TOOL AND WAS UNSUCCESSFUL DUE TO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY. DEVICE WAS CUT OPEN AND PCBA2 WAS SWAPPED WITH TEST PCB, INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. MOISTURE DAMAGE WAS FOUND ON THE KEYPAD CONNECTOR ON J1/PCBA1, J6 CONNECTOR INTERNAL BATTERY, J7 POWER CONNECTOR, MOTOR AND FORCE SENSOR DURING VISUAL INSPECTION. UNABLE TO PERFORM THE FUNCTIONAL TESTS, INCLUDING THE DISPLACEMENT TEST, REWIND, PRIME/SEATING, BASIC OCCLUSION, OCCLUSION, FORCE SENSOR, SELF TEST, SLEEP CURRENT MEASUREMENT, AND ACTIVE CURRENT MEASUREMENT DUE TO THE CRITICAL PUMP ERROR. DEVICE WAS RECEIVED WITH A MISSING DISPLAY WINDOW COVER, CRACKED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE) AND CRACKED BATTERY TUBE THREADS. 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 HAD OTHER CRITICAL PUMP ERROR ALARM. CUSTOMER STATED THAT THEY WENT TO THE WATER PARK AND SHOWER WITH INSULIN PUMP AND NO CRACKS WERE OBSERVED. 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
    1097179 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG3NEQ6 000000763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR