BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 10565763 · Received September 22, 2020

    Report

    Report Number
    2954323-2020-06388
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 10, 2020
    Report Date
    October 20, 2020
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    UDI-DI
    00699073709141
    PMA / PMN Number
    K092602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED METER WAS INVESTIGATED WITH RETAINED TEST STRIPS. METER POWERED ON WITH BUTTON DEPRESSION AND TEST STRIP INSERTION. NO NEW ISSUES WERE OBSERVED. BLANK SCREEN WAS NOT OBSERVED. THE COMPLAINT WAS NOT CONFIRMED. THIS SERVES AS A CORRECTION REPORT. SECTION G5 (PMA/510(K)) WAS INCORRECTLY DOCUMENTED IN INITIAL REPORT. THE CORRECT G5 (PMA/510(K)) SHOULD BE K092602.

    Description of Event or Problem · 0

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    AN EXTENDED INVESTIGATION HAS BEEN CONDUCTED, WHICH INVOLVED A MANUFACTURING REVIEW (INCLUDING 5 YEARS OF DEVICE HISTORY RECORDS (DHRS)), PREVIOUS COMPLAINT AND CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATIONS CONDUCTED FOR BLANK SCREEN ISSUES, PROCESS FAILURE MODE EFFECTS ANALYSES (PFMEAS), DESIGN CONTROLS, AND DESIGN FAILURE MODE EFFECTS ANALYSES (DFMEAS), RISK MANAGEMENT REPORTS, RISK EVALUATIONS, AND LABEL COPY. THE INVESTIGATION DID NOT IDENTIFY ANY INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. IF THE PRODUCT IS RETURNED, AN INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. 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
    1035405 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 70914-70 00699073709141

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR