BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREE STYLE LIBRE SENSOR

    MDR report key: 23887527 · Received December 23, 2025

    Report

    Report Number
    MW5181135
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USED 2 FREE STYLE LIBRE SENSORS LOT # T60003449 AND T60003442 BOTH FAILED TO OPERATE THE FULL 14 DAYS LASTED ONLY 7 DAYS EACH, FAILED TO CONNECT MULTIPLE TIMES AND THE SUGARS SHOWN WAS 90 POINTS LESS THAN THE ORIGINAL FINGERS STICK TEST. PATIENT WAS MONITORING HIGH SUGARS DUE TO STEROID THERAPY, AND ENDED UP IN HOSPITAL AFTER ONE WEEK FOR PANCREATITIS FLARE UP DUE TO HIGH SUGARS. CVS FILLED RX AND REPORTED RECALL ON SENSORS BUT ABBOTT FREESTYLE LIBRE CUSTOMER SERVICE AT 1833-815-4273 SAYS THAT LOT NUMBERS WERE NOT AFFECTED. JUST REPORTING THAT NOT ONLY LOW SUGARS BUT HIGH SUGARS READINGS AND DISCREPANCY IN THE SENSOR READINGS ARE AFFECTING CUSTOMERS. MOST INSURANCE DO NOT COVER THESE PRODUCTS. PATIENT CODE: 1905, 4481. DEVICE CODE: 1535, 2978. REFERENCE REPORT: MW5181136.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919336 FREE STYLE LIBRE SENSOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC. FREESTYLE T60003449

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Hospitalization AMLODIPINE.| FARXIGA.| LISINOPRIL.| METFORMIN.| VIT D.