BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 19354252 · Received May 20, 2024

    Report

    Report Number
    2954323-2024-17479
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    April 25, 2024
    Report Date
    May 20, 2024
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLJ
    UDI-DI
    30357599818006
    PMA / PMN Number
    K212132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    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 EXTRACTED ON THE RETURNED SENSOR WAS SUCCESSFUL. WATERMARK WAS OBSERVED AT THE BASE OF THE SENSOR TAIL INDICATING THAT THE SENSOR TAIL WAS PROPERLY INSERTED. THE RETURNED SENSOR WAS FURTHER INVESTIGATED AND DE-CASED. AN INTERNAL VISUAL INSPECTION WAS PERFORMED ON THE SENSOR¿S PCBA (PRINTED CIRCUIT BOARD ASSEMBLY); NO ISSUES WERE OBSERVED. PERFORMED AN SMU (SOURCE MEASUREMENT UNIT) TEST WITH 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 BOTH WITHIN SPECIFICATION, INDICATING THE SENSOR WAS PROVIDING ACCURATE GLUCOSE READINGS. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. THEREFORE, THIS ISSUE IS NOT CONFIRMED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT. THE DHR (DEVICE HISTORY REPORT) FOR THE LIBRE SENSOR AND SENSOR KIT WAS REVIEWED, AND SHOWED THE LIBRE SENSOR AND SENSOR KITS PASSED ALL TESTS PRIOR TO RELEASE AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A HIGH GLUCOSE READINGS ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER EXPERIENCED THE FOLLOWING SYMPTOMS "SHAKINESS, FREEZING COLD, SWEATING, HEADACHE, NAUSEA, DIZZINESS", AND THEN A LOSS OF CONSCIOUSNESS. THE CUSTOMER RECEIVED TREATMENT FROM A HEALTHCARE PROFESSIONAL (HCP) WHO PROVIDED THE CUSTOMER WITH FOOD, GLUCOSE TABLETS, AND PERFORMED A FINGERSTICK BLOOD GLUCOSE TEST. THE CUSTOMER DID NOT PROVIDE ADDITIONAL DETAIL AS TO WHAT TYPE OF FOOD OR THE TABLET DOSAGE, BUT DID STATE THE TEST RESULTS CAME IN AT 38MG/DL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704480 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLJ ABBOTT DIABETES CARE LTD 72081-01 30357599818006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention