BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE PRECISION NEO

    MDR report key: 8863320 · Received August 6, 2019

    Report

    Report Number
    2954323-2019-05977
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    August 1, 2019
    Report Date
    October 11, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    PMA / PMN Number
    K140371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 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

    UNLESS FURTHER INFORMATION IS OBTAINED, THIS ISSUE IS CONSIDERED CLOSED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE RETURNED METER WAS INVESTIGATED. OBSERVED INDICATOR LIGHTS FLASHING UPON BATTERY INSERTION AND HIGH/LOW BLOOD GLUCOSE INDICATORS WAS ALSO OBSERVED. A DSPC-17 ISSUE WAS OBSERVED. THE REPORTED COMPLAINT WAS NOT CONFIRMED.

    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.

    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
    658023 FREESTYLE PRECISION NEO BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 71371-75

    Patients

    Seq Age Sex Outcome Treatment
    1