BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 17688020 · Received September 6, 2023

    Report

    Report Number
    2032227-2023-267659
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 18, 2023
    Report Date
    February 18, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000521554
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TEST, 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 THE DAT AT 0.0873 INCHES. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOT CONFIRMED. NO PUMP ERROR 68, PUMP ERROR 49, PUMP ERROR 23 ALARMS NOTED DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. THE PUMP WAS RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. PLEASE SEE BELOW FOR THE BOLUSES LISTED ON THE EVENT DATE 17-AUG-2023 IN THE PUMP HISTORY FILE. 08/17/2021 05:12:43.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 10000 (1 U), BOLUSAMOUNTDELIVERED: 10000 (1 U). 08/17/2021 05:16:57.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 5000 (0.5 U), BOLUSAMOUNTDELIVERED: 5000 (0.5 U). 08/17/2021 05:21:51.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 5000 (0.5 U), BOLUSAMOUNTDELIVERED: 5000 (0.5 U). 08/17/2021 06:54:57.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 15000 (1.5 U), BOLUSAMOUNTDELIVERED: 15000 (1.5 U). 08/17/2021 07:30:07.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 10000 (1 U), BOLUSAMOUNTDELIVERED: 10000 (1 U). 08/17/2021 07:32:55.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 5000 (0.5 U), BOLUSAMOUNTDELIVERED: 5000 (0.5 U). 08/17/2021 07:36:25.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1). NORMALBOLUSAMOUNTPROGRAMMED: 5000 (0.5 U). BOLUSAMOUNTDELIVERED: 5000 (0.5 U), 08/17/2021 07:42:35.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1)., NORMALBOLUSAMOUNTPROGRAMMED: 5000 (0.5 U), BOLUSAMOUNTDELIVERED: 5000 (0.5 U). 08/17/2021 07:59:09.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 10000 (1 U), BOLUSAMOUNTDELIVERED: 10000 (1 U). PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE 17-AUG-2023 IN THE PUMP HISTORY FILE. 08/17/2021 13:11:00.000 DAILYTOTALSG670 (63), DAILYTOTALCOLLECTIONSTARTTIME: 08/17/2021 00:00:00.000, DAILYTOTALOFALLINSULINDELIVERED: 148750 (14.875 U), DAILYTOTALOFBASALINSULINDELIVERED: 78750 (7.875 U), DAILYTOTALOFBOLUSINSULINDELIVERED: 70000 (7 U). THERE WERE NO AUTOSUSPEND (12) ALARM NOTED IN THE PUMP HISTORY FILE. THERE WERE NO USERSUSPENDED (2) ALARM NOTED ON THE EVENT DATE 17-AUG-2023 IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 17-AUG-2023 IN THE PUMP HISTORY FILE. 08/17/2021 11:40:39.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL. 08/17/2021 11:41:17.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL. 08/17/2021 11:43:03.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL. 08/17/2021 11:44:21.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL. 08/17/2021 11:54:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL. 08/17/2021 13:00:44.000 BATTERYREMOVED (55) 08/17/2021 13:00:44.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84). 08/17/2021 13:11:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84). 08/17/2021 16:17:44.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58). 08/17/2021 16:18:08.000 BATTERYREMOVED (55). 08/17/2021 16:18:08.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84). 08/17/2021 16:27:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58). 08/17/2021 16:56:34.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6). 08/17/2023 17:05:04.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL. 08/17/2023 17:07:21.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL. 08/17/2023 17:17:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL. 08/17/2023 17:18:41.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL. 08/17/2023 17:28:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL. 08/17/2023 17:28:55.000 BATTERYREMOVED (55). 08/17/2023 17:28:55.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84). 08/17/2023 17:39:10.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: TRACECHECKERROR (68). 08/17/2023 17:39:10.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: HISTORYPOINTERSBADALARM (49). 08/17/2023 17:40:39.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: HISTORYPOINTERSBADALARM (49). 08/17/2023 17:41:04.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: POSTRESETRAMCRCALARM (23). 08/17/2023 17:41:24.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6). 08/17/2023 17:41:32.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6). FAILED BATTERY TEST ALARM WAS EXPECTED DUE TO THE CUSTOMER'S BATTERY INSERTED ON A BATTERY CHANGE DOES NOT HAVE SUFFICIENT VOLTAGE. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. PUMP ERROR 23, PUMP ERROR 49, PUMP ERROR 68 AND BATTERY OUT LIMIT ALARM WERE EXPECTED DUE TO THE BATTERY REMOVED FOR MORE THAN 10 MINUTES AND THE PUMP RESET. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOT CONFIRMED. NODELIVERY (7) NOT CONFIRMED. FAILEDBATTTEST (58) NOT CONFIRMED. BATTOUTLIMIT (6) NOT CONFIRMED. PUMP ERROR 68 NOT CONFIRMED. PUMP ERROR 49 NOT CONFIRMED. PUMP ERROR 23 NOT CONFIRMED. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS/DKA. PUMP ERROR 68 NOT CONFIRMED. PUMP ERROR 49 NOT CONFIRMED. PUMP ERROR 23 NOT CONFIRMED. INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOT CONFIRMED. 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 · 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. 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. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED OUTSIDE 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 EXPERIENCED HYPERGLYCEMIA OF BLOOD GLUCOSE VALUE 330 MG/DL, ADMITTED IN HOSPITAL WITH DIABETIC KETOACIDOSIS DUE TO A PROBLEM WITH THE PUMP AND ALSO RECEIVED THE PUMP ERRORS POST-RESET RAM CRC ALARM (PUMP ERROR 23), HISTORY POINTERS FAILED. THE HISTORY POINTERS ARE CORRUPTED (PUMP ERROR 49) AND TRACE POINTERS ARE INVALID (PUMP ERROR 68). THE CUSTOMER ALSO REPORTS THAT THERE WAS INSULIN FLOW BLOCK ALARM. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER WAS ABLE TO CLEAR THE ALARM, COMPLETE REWIND AND PASSED THE SELF TEST SUCCESSFULLY. IT WAS UNKNOWN WHETHER THE CUSTOMER USED THE INSULIN PUMP WITHIN 48 HOURS OF THE EPISODE. IT WAS ALSO UNKNOWN WHETHER THE AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987108 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 HG60LF5ZZ 000000763000521554

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown