BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE RESULT

    MDR report key: 4628005 · Received March 19, 2015

    Report

    Report Number
    1052693-2015-00307
    Event Type
    Malfunction
    Date Received
    March 19, 2015
    Date of Event
    February 26, 2015
    Report Date
    March 19, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE IS: STRIP ISSUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO." CUSTOMER CALLED STATING HE GOT LO THREE TIMES TODAY. CUSTOMER IS FEELING WELL AND DOES NOT REQUIRE MEDICAL ATTENTION. VERIFIED THE STRIPS EXPIRE 02/24/2015. VERIFIED IMPROPER STORAGE, CUSTOMER STRIPS ARE EXPIRED AND ARE KEPT OUT OF VIAL. REVIEWED METER MEMORY: MEMORY 1: LO ON (B)(6) 2014 12:00:00 AM, MEMORY 2: LO ON (B)(6) 2015 12:00:00 AM, MEMORY 3: LO ON (B)(6) 2015 12:00:00 AM, MEMORY 4: 159 ON (B)(6) 2014 12:00:00 AM, MEMORY 5: 140 ON (B)(6) 2014 12:00:00 AM. TIME AND DATE IS NOT SET. CUSTOMER HAS USED THE STRIPS FOR A YEAR ((B)(6) 2014). HE DOES NOT HAVE ANY MORE STRIPS LEFT TO TROUBLE SHOOT. NO ADVERSE EVENT REPORTED. LO ON (B)(6) 2014 AT 07:24 PM, LO ON (B)(6) 2014 AT 07:22 PM, 112 MG/DL ON (B)(6) 2014 AT 01:16 PM, 128MG/DL ON (B)(6) 2014 AT 08:04 AM, 137MG/DL ON (B)(6) 2014 AT 11:24 PM. THE CUSTOMER STATES THAT SHE USUALLY WAITS AT LEAST TWO HOURS AFTER EATING, DRINKING, EXERCISING, OR TAKING ANY MEDICATION BEFORE PERFORMING A BLOOD TEST. THE CUSTOMER IS ON MEDICATIONS FOR DIABETES (METFORMIN). THE CUSTOMER STATES THAT SHE FEELS FINE AND DOES NOT NEED ANY MEDICAL INTERVENTION. I INFORMED THE CUSTOMER TO DISCONTINUE USING THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189264 TRUE RESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUE RESULT PP1209

    Patients

    Seq Age Sex Outcome Treatment
    1