BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12273351 · Received August 4, 2021

    Report

    Report Number
    2032227-2021-176268
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 23, 2021
    Report Date
    November 1, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: (B)(6), 2021. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. FUNCTIONAL TESTING TO BE PERFORMED/COMPLETED: THE INSULIN PUMP WAS RECEIVED WITH A SCRATCHED CASE, A CRACKED KEYPAD OVERLAY, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A PILLOWING KEYPAD OVERLAY. THE TEST P-CAP/RESERVOIR DOES LOCK PROPERLY INSIDE THE RESERVOIR TUBE. THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. NO BLANK DISPLAY NOTED. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST. THE INSULIN PUMP HISTORY FILE/TRACES DOWNLOAD WAS SUCCESSFUL USING THUS. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPECIFIC RANGE. THE INSULIN PUMP WAS MONITORED AND NO UNEXPECTED POWERING OFF OR BLANK DISPLAY NOTED. THERE WAS NO UNEXPECTED POWER ERROR 25, REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM IN THE FORMATTED HISTORY FILE ON THE EVENT DATE: (B)(6), 2021. HOWEVER, LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 01:55:00.000 ALARM ALERT NOTIFICATION (B)(6) 2021 02:25:22.000 ALARM ALERT CLEARED (B)(6) 2021 19:37:00.000 ALARM ALERT NOTIFICATION (B)(6) 2021 19:37:17.000 ALARM ALERT CLEARED (B)(6) 2021 08:17:00.000 ALARM ALERT NOTIFICATION (B)(6) 2021 08:17:26.000 ALARM ALERT CLEARED AND POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 08:29:24.000 ALARM ALERT NOTIFICATION (B)(6) 2021 08:29:48.000 ALARM ALERT NOTIFICATION (B)(6) 2021 08:30:01.000 ALARM ALERT CLEARED. THE INSULIN PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO ELECTRICAL BOARD 1. NO LOOSE ELECTRONIC COMPONENTS OR MOISTURE DAMAGE FOUND ON THE ELECTRONIC ASSEMBLY, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FAILURE ANALYSIS SUMMARY: THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE INSULIN PUMP WAS MONITORED FOR SEVERAL DAYS AND NO UNEXPECTED POWERING OFF OR BLANK DISPLAY NOTED. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 BLANK DISPLAY. THE TROUBLESHOOTING WAS PERFORMED. THE DISPLAY DID NOT RETURN AFTER PUMP RESTART. 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
    1174058 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG3U8Q7 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR