BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 20936136 · Received December 16, 2024

    Report

    Report Number
    2032227-2024-286361
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    August 26, 2024
    Report Date
    January 10, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08765 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 26-AUG-2024, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE OF 26-AUG-2024 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: (B)(6) 2024 00:00:00.000. DAILYTOTALOFALLINSULINDELIVERED: 592750 (59.275 U). DAILYTOTALOFBASALINSULINDELIVERED: 349250 (34.925 U). DAILYTOTALOFBOLUSINSULINDELIVERED: 243500 (24.35 U). (B)(6) 2024 06:58:25.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1). NORMALBOLUSAMOUNTPROGRAMMED: 38000 (3.8 U). BOLUSAMOUNTDELIVERED: 38000 (3.8 U). (B)(6) 2024 08:02:31.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1). NORMALBOLUSAMOUNTPROGRAMMED: 11500 (1.15 U). BOLUSAMOUNTDELIVERED: 11500 (1.15 U). (B)(6) 2024 13:09:21.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1). NORMALBOLUSAMOUNTPROGRAMMED: 176000 (17.6 U). BOLUSAMOUNTDELIVERED: 176000 (17.6 U). (B)(6) 2024 16:24:39.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1). NORMALBOLUSAMOUNTPROGRAMMED: 18000 (1.8 U). BOLUSAMOUNTDELIVERED: 18000 (1.8 U). PER R&D ENGINEER MARK FREGER, THERE WAS NO UNPROGRAMMED DELIVERED BOLUS IN THE AMOUNT ~ 23U (SEE ATTACHED DETAILED R&D ANALYSIS). PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 26-AUG-2024 IN THE FORMATTED HISTORY FILE. LOSTSENSOR1ALERT (780) WAS FOUND ON: (B)(6) 2024 08:13:00.000. SGCALIBRATIONERROR (776) WAS FOUND ON: (B)(6) 2024 03:29:53.000. (B)(6) 2024 05:39:48.000. THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. THE PUMP WAS PROGRAMMED WITH BASAL PROFILES AND MONITORED. ALL BASAL PROFILES DELIVERED THEIR INDICATED AMOUNTS AND WERE VERIFIED IN THE DAILY AND SUMMARY HISTORY SCREENS. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A GLUCOSE SENSOR SIMULATOR. AUTO MODE SMARTGUARD WAS TURNED ON, PROGRAMMED THE AUTO MODE SMARTGUARD SETTINGS TARGET TO 100 MG/DL. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 90 MG/DL PROPERLY ON THE DISPLAY GRAPH. THE AUTO MODE HAS BEEN AT THE MINIMUM DELIVERY LIMIT FOR 2 1/2 HOURS. A ENTER BG NOW MESSAGE - SMARTGUARD HAS REACHED THE TIME LIMIT FOR MINIMUM DELIVERY RATE. ENTER BG TO CONTINUE IN SMARTGUARD WAS TRIGGERED PROPERLY DURING TESTING. THE PUMP SENSOR FEATURE AND THE AUTO MODE CONNECTION ARE WORKING PROPERLY. NO LOST SENSOR ALERT, SG CALIBRATION ERROR, SENSOR RELATED ERRORS/ANOMALIES, NO AUTO MODE ANOMALY, HISTORY ANOMALY, DELIVERY ANOMALY, BOLUS/BASAL ANOMALY, UNDER DELIVERY/OVER DELIVERY ANOMALY AND AUDIO/VIBRATE ANOMALY/ABSENCE OF ALARM (MIN DELIVERY ALERT WENT OFF) ANOMALY NOTED DURING TESTING. ALL AUDIO TONES WERE HEARD DURING THE SELF TEST PROPERLY. ADJUSTED THE AUDIO OPTIONS AUDIO VOLUME 1-5 AND EACH SETTING FUNCTIONED PROPERLY. NO UNEXPECTED AUDIO/VIBRATE ANOMALY/ABSENCE OF ALARM OR PUMP ERROR 63 ALARMS IN THE FORMATTED HISTORY NOTED DURING TESTING. THE 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. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (24.1 MV). THE PUMP WAS RECEIVED WITHOUT A BATTERY CAP INSTALLED. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. THE MOLDING KNIT LINE DAMAGE (NEAR THE BELT CLIP PLATE) WAS ACCEPTABLE PER CASE ASSEMBLY COSMETIC SPECIFICATION, (B)(4). THE SC1 CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. CUSTOMER ALLEGED FOR POSSIBLE OVER DELIVERY ANOMALY/BOLUS DELIVERY ANOMALY AND AUDIO/VIBRATE ANOMALY/ABSENCE OF ALARM (MIN DELIVERY ALERT WENT OFF) ANOMALY WERE NOT CONFIRMED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    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 REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED AUDIO/VIBRATE ANOMALY/ABSENCE OF ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1886. THE CUSTOMER CALLED FOR AN ISSUE NOT COVERED BY EXISTING TROUBLESHOOTING GUIDES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER WILL DISCONTINUE TO USE OF THE DEVICE. MMT-1886 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2382575 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 NG3588180H

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown