BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 22055953 · Received May 20, 2025

    Report

    Report Number
    2954323-2025-18310
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    May 1, 2025
    Report Date
    May 21, 2026
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLJ
    UDI-DI
    05021791002658
    PMA / PMN Number
    K212132
    Removal / Correction Number
    2954323-11/22/25-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION AND THE CUSTOMER AGREED TO RETURN THE DEVICE; HOWEVER, AT THIS TIME PRODUCT HAS NOT YET BEEN RECEIVED. A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. AN INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. CLINICAL DATA WAS REVIEWED AND CONFIRMED THAT FREESTYLE LIBRE SENSORS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. STABILITY DATA FOR FREESTYLE LIBRE SENSORS WAS REVIEWED AND SHOWED NO ANOMALIES OR NON-CONFORMANCES THAT COULD HAVE LED TO THE COMPLAINT. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND FREESTYLE LIBRE SENSORS, NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. THE MOST PROBABLE ROOT CAUSES ASSOCIATED WITH THIS FAILURE MODE ARE DISCONNECTED, FAULTY OR DAMAGED COMPONENTS, SOFTWARE/DATA CORRUPTION, OR MISUSE. HOWEVER, MITIGATIONS ARE IN PLACE TO REDUCE AND PREVENT SUCH ISSUES. ALL VITAL MANUFACTURING STEPS ARE VALIDATED, MONITORED, AND VERIFIED DURING MANUFACTURING TO ENSURE THE SYSTEM IS IN CONFORMANCE WITH THE VERIFIED DESIGN. ALL VITAL FUNCTIONS ARE MONITORED BY THE SYSTEM AND, WHEN NECESSARY, FUNCTION IS SUSPENDED TO SAFEGUARD AGAINST INACCURATE RESULTS. LABELING IS PROVIDED TO INSTRUCT THE USER ON THE INTENDED USE OF ALL VITAL PARTS OF THE SYSTEM TO MINIMIZE MISUSE. ALL COMPLAINTS AND COMPLAINT TRENDS ARE INVESTIGATED TO DETERMINE IF THERE IS A PRODUCT DEFECT/ DEFICIENCY. IF A PRODUCT DEFECT/ DEFICIENCY IS IDENTIFIED, A RISK EVALUATION IS COMPLETED AND COMPARED TO THE RISK MANAGEMENT REPORT, TO ENSURE THE RISK PROFILE HAS NOT CHANGED. ADDITIONALLY, AS A PART OF ABBOTT¿S POST-MARKET SURVEILLANCE PROCESS, ALL RISK EVALUATIONS WITH ASSOCIATED COMPLAINT DATA ARE REVIEWED ANNUALLY TO DETERMINE IF THE RISK PROFILES HAVE CHANGED AS COMPARED TO THE PRODUCT RISK MANAGEMENT REPORTS. THESE MONITORING PROCESSES ENSURE THAT ALL PRODUCT RISK PROFILES REMAIN ACCEPTABLE AND HAVE A POSITIVE BENEFIT/ RISK RATIO. IF PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED PER ADC'S ESTABLISHED PROCESSES AND PROCEDURES AND A REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION PERFORMED ON THE RETURNED SENSOR PATCH AND NO ISSUE WAS OBSERVED. DATA WAS EXTRACTED USING APPROVED SOFTWARE AND EXTRACTION WAS SUCCESSFUL. THE WATERMARK WAS OBSERVED AT THE BASE OF THE TAIL INDICATING THE SENSOR BEING PROPERLY INSERTED. SENSOR STATE 7 WITH EVENT LOG 11 AND SENSOR STATE 8 WITH EVENT LOG 9 ARE AN INDICATION THAT THE SENSOR HAD TERMINATED DUE TO AN ERROR RECOGNIZED BY THE SENSOR. THIS IS A PART OF SOFTWARE DESIGN AND IS NOT AN INDICATION OF PRODUCT NON-CONFORMANCE. FUNCTIONALITY TEST WILL BE PERFORMED ON THE SENSOR TO VERIFY IF SENSOR IS FUNCTIONING AS INTENDED. THE RETURNED SENSOR WAS FURTHER INVESTIGATED AND DE-CASED. PERFORMED AN INTERNAL VISUAL INSPECTION ON THE SENSOR¿S PCBA (PRINTED CIRCUIT BOARD ASSEMBLY); NO ISSUES WERE OBSERVED. PERFORMED AN SMU (SOURCE MEASUREMENT UNIT) TEST USING CONNECTOR KEY TO ENSURE THE SENSOR'S ELECTRONICS WERE FUNCTIONING CORRECTLY AND THE RETURNED UNIT DID NOT HAVE ANY GLUCOSE READING ISSUES. POISE VOLTAGE AND SENSOR THERMISTOR TESTING WERE PERFORMED, HOWEVER, SENSOR THERMISTOR TEST WAS NOT WITHIN THE SPECIFICATIONS. FURTHER INVESTIGATION WAS CONDUCTED, WHERE A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SENSOR PUCK AND THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE INSPECTION WAS REVEALED THAT NO ISSUE OF CONTAMINATION AND NO COMPONENT DAMAGE WAS OBSERVED. THE INITIAL SCAN WAS REVIEWED AND OBSERVED THAT THE SENSOR WAS ACTIVATED. TO CONFIRM THE FUNCTIONALITY OF THE RETURNED SENSOR. AN SMU (SOURCE MEASUREMENT UNIT) TEST WAS PERFORMED TO ENSURE THE SENSOR'S ELECTRONICS WERE FUNCTIONING CORRECTLY AND THE RETURNED UNIT DID NOT HAVE ANY GLUCOSE READING ISSUES. POISE VOLTAGE AND SENSOR THERMISTOR TESTING WERE BOTH WITHIN SPECIFICATION, INDICATING THE SENSOR WAS PROVIDING ACCURATE GLUCOSE READINGS. THE PASSING OF FUNCTIONALITY TESTING IS AN INDICATION THAT THERE WERE NO ISSUES WITH SENSOR FUNCTIONALITY AND ELECTRONICS. THE CUSTOMER¿S REPORTED ISSUE IS THEREFORE NOT CONFIRMED AS THE SENSOR PASSED ALL TESTS DURING MANUFACTURING AND AT RELEASE. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR AND SENSOR KIT WAS REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR AND SENSOR KIT MET SPECIFICATIONS PRIOR TO RELEASE TO DISTRIBUTION. SECTION H4 (DEVICE MFG DATE) WAS UPDATED BASED ON RETURNED PRODUCT DOWNLOAD. SECTION D4 (SERIAL NUMBER) WAS UPDATED FROM (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE CUSTOMER RECEIVED SENSOR SCAN RESULTS OF 59 MG/DL COMPARED TO READINGS OF X265 MG/DL RESPECTIVELY OBTAINED IN THE LABORATORY AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE C ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE CUSTOMER NOTED A VERTICAL TREND ARROW WHICH INDICATES RAPIDLY RISING/DECLINING GLUCOSE LEVELS (MORE THAN 2 MG/DL PER MINUTE). THE LENGTH OF SENSOR WEAR WAS 2 DAYS. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE CUSTOMER RECEIVED SENSOR SCAN RESULTS OF 59 MG/DL COMPARED TO READINGS OF 265 MG/DL RESPECTIVELY OBTAINED IN THE LABORATORY AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE C ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE CUSTOMER NOTED A VERTICAL TREND ARROW WHICH INDICATES RAPIDLY RISING/DECLINING GLUCOSE LEVELS (MORE THAN 2 MG/DL PER MINUTE). THE LENGTH OF SENSOR WEAR WAS 2 DAYS. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502076 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLJ ABBOTT DIABETES CARE LTD 72081-01 T60002861 05021791002658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown