BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 4730780 · Received April 17, 2015

    Report

    Report Number
    1052693-2015-00449
    Event Type
    Malfunction
    Date Received
    April 17, 2015
    Date of Event
    July 18, 2013
    Report Date
    April 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. INTERNAL REPORT # (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 OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. HER READINGS 90-110 IN MORNING FASTING RESULTS IN MEMORY: (B)(6) 2013, 128 PM, 64; (B)(6) 2013, 709 AM, 63; (B)(6) 2013, 825 AM, 79; (B)(6) 2013, 723 AM, 97; (B)(6)2013, 708 AM, 109; (B)(6) 2013, 605 AM, 94. BACK TO BACK BLOOD TEST 129, 119. BASED ON THE CUSTOMERS EXPECTED RESULTS (90-110) AND THE LOWEST RESULT IN MEMORY (63). THE COMPLAINT IS REPORTABLE. (ZONE B/C). ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256307 NONE LFR NIPRO DIAGNOSTICS, INC. TRESULT PP1285

    Patients

    Seq Age Sex Outcome Treatment
    1