BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOCARD VITAL BLOOD GLUCOSE SYSTEM

    MDR report key: 3810602 · Received May 14, 2014

    Report

    Report Number
    1832816-2014-00042
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 26, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED. PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE GLUCOCARD VITAL METER WAS PRODUCING VARIABLE READINGS. CUSTOMER CALLED FOR ASSISTANCE GETTING THE STRIP INTO THE METER. CALLER WAS ABLE TO GET THE STRIP IN AND PERFORM A BLOOD TEST. THE READING WAS LO. SHE DID A SECOND TEST AND GOT 121. THESE READINGS WERE PERFORMED BACK TO BACK AND THE VARIANCE IS OUTSIDE ACCEPTABLE PARAMETERS. STORAGE AND TECHNIQUE ARE GOOD. CONTROL TEST IN RANGE. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288706 GLUCOCARD VITAL BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 761100 07013B

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR