BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 12480132 · Received September 16, 2021

    Report

    Report Number
    2032227-2021-193791
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    September 6, 2021
    Report Date
    November 18, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TIME AND DATE OF HOSPITALIZATION: 12PM AND (B)(6) 2021. HIGH BLOOD GLUCOSE, UNCONSCIOUS, KETONES. CUSTOMER RESPONSE: THE INSULIN PUMP IS NOT DELIVERING AS IT SHOULD. DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW AND A SCRATCHED CASE. 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. DEVICE 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 DELIVERY ACCURACY TEST AT 0.0873 INCHES. NO UNDER DELIVERY ANOMALY NOTED. PLEASE SEE BELOW FOR THE DAILY TOTAL COLLECTION START TIME: (B)(6) 2021 00:00:00.000 AND DAILY TOTAL OF BOLUS INSULIN DELIVERED = 5 U. 09/07/2021 00:00:00.000 DAILYTOTALSG670 (63), DAILYTOTALCOLLECTIONSTARTTIME: 09/06/2021 00:00:00.000, DAILYTOTALOFBOLUSINSULINDELIVERED: 50000 (5 U), PLEASE SEE BELOW FOR THE BOLUSES LISTED ON (B)(6) 2021. (B)(6) 2021 11:38:31.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1GLUCOSECORRECTION (6) NORMALBOLUSAMOUNTPROGRAMMED: 39000 (3.9 U), BOLUSAMOUNTDELIVERED: 39000 (3.9 U), (B)(6) 2021 23:11:13.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1AUTOBOLUS (9), NORMALBOLUSAMOUNTPROGRAMMED: 11000 (1.1 U), BOLUSAMOUNTDELIVERED: 11000 (1.1 U). NO UNEXPECTED INSULIN FLOW BLOCK ALARM OR SUSPEND ANOMALY NOTED ON (B)(6) 20021. DEVICE WAS PROGRAMMED WITH MULTIPLE TEST BOLUSES AND MONITORED USING THE BOLUS WIZARD FEATURE. THE DEVICE DELIVERED THE ESTIMATED BOLUS AMOUNT PROPERLY AND ALL BOLUSES WAS LISTED IN THE DEVICE DAILY HISTORY SCREEN. NO BOLUS DELIVERY ANOMALY NOTED. DEVICE PASSED THE FUNCTIONAL TESTING. NO UNDER DELIVERY ANOMALY NOTED. UNABLE TO CONFIRM ALLEGED HIGH BLOOD GLUCOSE. 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.

    Description of Event or Problem · 0

    .

    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 WAS UNDER DELIVERING BECAUSE BLOOD GLUCOSE WAS NOT GOING DOWN. CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL OF 27.6 MMOL/L AND DIABETES KETOACIDOSIS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381908 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 HG56QFWZZ 000000763000384272

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown