BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CARELINK

    MDR report key: 21455403 · Received February 25, 2025

    Report

    Report Number
    2032227-2025-128516
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    March 7, 2022
    Report Date
    September 26, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THIS IS 1 OF 2 MEDWATCH REPORTS REGARDING THIS EVENT. WARE, JULIA. "CAMBRIDGE HYBRID CLOSED-LOOP ALGORITHM IN CHILDREN AND ADOLESCENTS WITH TYPE 1 DIABETES: A MULTICENTRE 6-MONTH RANDOMISED CONTROLLED TRIAL". LANCET DIGIT HEALTH, VOLUME 4, ISSUE 4, 2022, HTTPS://DOI.ORG/10.1016/S2589-7500(22)00020-6. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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

    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 IN THE PUBLISHED LITERATURE REGARDING THE "CAMBRIDGE CONTROL ALGORITHM, WHICH WAS USED IN A CLINICAL TRIAL INVOLVING A MEDTRONIC PROTOTYPE PHONE ENCLOSURE AND A MODIFIED MEDTRONIC MINIMED 640G INSULIN PUMP". THE INSULIN PUMP, INTEGRATED WITH THE MEDTRONIC MINIMED GUARDIAN 3 SENSOR, WAS EQUIPPED WITH THE LOW GLUCOSE SUSPEND FEATURE AND REQUIRED REGULAR FINGER PRICK CALIBRATIONS. THIS SETUP AIMED TO ENABLE THE SMARTPHONE TO WIRELESSLY COMMUNICATE WITH THE INSULIN PUMP THROUGH AN EMBEDDED MODIFIED CARELINK USB. HOWEVER, THE TRIAL ENCOUNTERED SIGNIFICANT HARDWARE CHALLENGES EARLY ON, WHICH WORSENED AS THE STUDY PROGRESSED. A MAJOR ISSUE AROSE WITH THE EMBEDDED CARELINK USB IN THE SMARTPHONE ENCLOSURE. THE USB, WHICH WAS SOURCED FROM A REPLACEMENT SUPPLIER AFTER THE STUDY HAD STARTED, FAILED DUE TO OVERHEATING, WHICH RESULTED IN THE DISABLING OF COMMUNICATION BETWEEN THE SMARTPHONE AND THE INSULIN PUMP. THIS FAILURE SEVERELY IMPACTED THE ADHERENCE TO THE TRIAL PROTOCOL AND SIGNIFICANTLY LIMITED THE USAGE OF THE CLOSED-LOOP SYSTEM. THE FAILURE OF THE CARELINK USB DEVICE AND THE SUBSEQUENT COMMUNICATION ISSUES HINDERED THE EXPECTED FUNCTIONING OF THE SYSTEM, POTENTIALLY AFFECTING THE TRIAL OUTCOMES. NO SPECIFIC RESOLUTION FOR THESE HARDWARE CHALLENGES WAS IDENTIFIED DURING THE TRIAL. ADDITIONALLY, THIS MALFUNCTION REDUCED THE OVERALL EFFICIENCY AND RELIABILITY OF THE CLOSED-LOOP INSULIN DELIVERY SYSTEM, WHICH IS ESSENTIAL FOR PATIENTS' HEALTH MANAGEMENT. IT WAS UNKNOWN IN THE STUDY WHETHER THESE ISSUES WERE RESOLVED. NO PRODUCTS WERE RETURNED FOR ANALYSIS AS A RESULT OF THE STUDY'S FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667207 UNKNOWN CARELINK SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC PUERTO RICO OPERATIONS CO. UNK_CARELINKSOFTWARE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown