BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY

    MDR report key: 14021319 · Received April 5, 2022

    Report

    Report Number
    MW5108772
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    February 6, 2022
    Report Date
    March 25, 2022
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    PZE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NARRATIVE: PATIENT WAS PRESCRIBED FREESTYLE LIBRE 14 DAY CGM SYSTEM PATIENT REPORTED INCONGRUENT READINGS BETWEEN FINGERSTICK AND CGM. AUTHOR DISCUSSED WITH PATIENT. PATIENT ENDORSED APPROPRIATE SENSOR APPLICATION TECHNIQUE AND APPROPRIATE SENSOR STORAGE. PATIENT DENIES DEHYDRATION DURING TIMES OF INCONGRUENT READINGS. PATIENT DENIES USE OF HIGH DOSE ASCORBIC ACID OR HIGH DOSE SALICYLIC ACID. PATIENT DENIES TAKING THE SENSOR THROUGH MRI/CT/X­-RAY/HOT TUB/SAUNA. PATIENT IS NOT ON DIALYSIS AND DOES NOT HAVE A PACEMAKER. PATIENT STATES HE HAS ATTEMPTED TO REPLACE SENSORS WHEN THIS HAPPENS. HIS BLOOD GLUCOSE TEST STRIPS WERE IN DATE. PATIENT DID NOTE THAT HE WAS NOT PUTTING THE SENSOR AND APPLICATOR TOGETHER ON A FIRM SURFACE. DATE TIME FINGERSTICK BG READING FREESTYLE LIBRE CGM SYSTEM READING (B)(6) 2022 1153 PM 97 54; (B)(6) 2022 1208 AM 93 62. PATIENT STATES THAT THE ABOVE READINGS WERE NOT TAKEN RIGHT AFTER EATING, DOSING INSULIN, OR EXERCISING. PATIENT WAS SWITCHED TO DEXCOM G6 CGM. READINGS AS BELOW. DATE TIME: FINGERSTICK CGM (B)(6) 2022 11 AM 98 97, 6 PM 129 129, 10 PM 110 113; (B)(6) 2022 12 AM 130 131, 11 AM 105 106, 6 PM 119 117, 10 PM 139 110; (B)(6) 2022 12 AM 139 148. SYMPTOM : SUSPECT DRUG# 1, DOSING: USE EVERY 14 DAYS FOR BLOOD GLUCOSE MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166589 GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED PZE ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male