BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS OPT B-KET-NO CODING

    MDR report key: 16625742 · Received March 28, 2023

    Report

    Report Number
    2954323-2023-12275
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    March 7, 2023
    Report Date
    April 10, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    METER (B)(6) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED ON THE RETURNED READER. THE CONTROL SOLUTION TESTING WAS PERFORMED AND NO ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. 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 RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO EITHER THE C, D, OR E ZONE. 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 RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO EITHER THE C, D, OR E ZONE. 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
    28273 FS OPT B-KET-NO CODING FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71953-01 4500186485

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown