BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ACTIVE

    MDR report key: 3955278 · Received July 24, 2014

    Report

    Report Number
    1823260-2014-05497
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 30, 2012
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATES THAT THE ACTIVE SYSTEM READS IN THE INCORRECT UNIT OF MEASURE FOR THE INTENDED DISTRIBUTION SITE. THE DEVICE READS IN MMOL/L, RATHER THAN MG/DL AS THIS DISTRIBUTION SITE IS INTENDED TO RECEIVE. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433531 ACCU-CHEK ® ACTIVE BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female