BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4821534 · Received April 15, 2015

    Report

    Report Number
    1052693-2015-00629
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    August 21, 2013
    Report Date
    April 15, 2015
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED FOR EVAL. (B)(4). MFR ACKNOWLEDGES LATENESS OF THE REPORT, PER INTERNAL CORRECTIVE ACTION. THIS REPORT SHOULD HAVE BEEN IDENTIFIED AS REPORTABLE WITHIN 30 DAYS OF THE IDENTIFICATION ((B)(6) 2013). MOST LIKELY UNDERLYING ROOT CAUSE: USE HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. VERIFIED THE STRIPS EXPIRE 03/31/2015. CUSTOMER STATES THAT HIS EXPECTED RANGE IS 150-200MG/DL. CHECK MEMORY FOR PREVIOUS RESULTS:(B)(6), 2:21PM, 100; (B)(6), 10:00AM, 120; (B)(6), 7:04AM, 128; (B)(6), 12:58PM, 125; (B)(6), 9:26PM, 125; (B)(6), 1:17PM, 123; (B)(6), 7:35AM, 135. CUSTOMER RAN BACK TO BACK TEST, 157MG/DL AND 151MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249899 TRUERESULT BLOOD GLUCOSE SYSTEM NBW HOME DIAGNOSTICS, INC. TRUERESULT PP1264

    Patients

    Seq Age Sex Outcome Treatment
    1