BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 16909378 · Received May 11, 2023

    Report

    Report Number
    2032227-2023-205831
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    February 8, 2023
    Report Date
    May 11, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384289
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE PUMP WAS RECEIVED WITH A SCRATCHED CASE. NO CRACK WAS FOUND NEAR THE DISPLAY NOTED DURING VISUAL INSPECTION. THE PUMP PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08700 INCHES. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS/ALERTS NOTED DURING THE TESTING. NO POWER ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE ON THE EVENT DATE. HOWEVER, LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/02/2023 07:00:00.000 REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/02/2023 16:31:00.000 02/02/2023 16:41:00.000 REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/02/2023 17:02:00.000 02/02/2023 17:12:00.000 POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/02/2023 17:13:19.000 02/02/2023 17:13:27.000 PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/02/2023 17:13:03.000 INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/08/2023 14:05:39.000 INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WERE EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER. THE CUSTOMER MAY HAVE USED A LOW POWER BATTERY. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE PUMP RESETS DUE TO BATTERY BACKUP DEPLETION. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE ORIGINAL PCBA 2 WAS INSTALLED IN A TEST PCBA 1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS INSTALLED IN A TEST PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS INSTALLED IN THE ORIGINAL PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE PUMP HAD AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS), SUSPECTED ON THE PCBA 1/PCBA 2. THERE WERE NO UNEXPECTED PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE (B)(6) 2023 IN THE FORMATTED HISTORY FILE. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.1 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. THE PUMP WAS RECEIVED WITHOUT A BATTERY CAP INSTALLED. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A CRACKED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. COSMETIC DAMAGE NEAR THE DISPLAY WAS NOT CONFIRMED, HOWEVER, OTHER COSMETIC DAMAGE WAS NOTED. AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WAS CONFIRMED, SUSPECTED ON THE PCBA 1/PCBA 2. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE NGP 780G INSULIN PUMP WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN PUMP, WHICH IS MARKETED IN THE UNITED STATES. 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED CRACK ON THE PUMP. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND THE PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864743 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 000000763000384289

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown