BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBRE 3

    MDR report key: 20090418 · Received August 27, 2024

    Report

    Report Number
    MW5158910
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 21, 2024
    Report Date
    August 21, 2024
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS HAS HAPPENED IN THE PAST AS WELL. THE LIBRE 3 HAS DEFECTS. LIBRE READS IN 50S AND 60S AND GLUCOMETER READS 110 OR HIGHER. NOT RELIABLE, CAUSED N=ME TO GO TO ER AS I WAS TREATING THE LOW LIBRE READING WHEN IT WAS ACTUALLY 60-130 POINTS HIGHER THAN LIBRE READING. WENT TO THE ER THIS DAY BECAUSE WAS TREATING LOW BLOOD GLUCOSE READINGS AND WAS CONCERNED. BLOOD SUGAR WAS 62, 53, 54, 53, 69, 69, 66, 54. BLOOD SUGAR WOULD NOT COME UP. USED GLUCAGON PEN AS WELL. WENT TO ER AND BLOOD DRAW WAS 184. ALARM GOING OFF ALL NIGHT BUT BLOOD SUGAR IS NOT LOW. THREW BOX AWAY AFTER APPLYING; CATALOG, LOT, SERIAL, AND UDI NUMBERS ALL UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180325 LIBRE 3 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other ACCUCHEK GUIDEME GLUCOMETER | ALBUTEROL | AVAPRO | BIOTIN | LANTUS| MAXZIDE | TIAZAC