BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201 MICROCUVETTES

    MDR report key: 3379377 · Received September 3, 2013

    Report

    Report Number
    3003044483-2013-00019
    Event Type
    Malfunction
    Date Received
    September 3, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    HEMOCUE AB
    Product Code
    LFR
    PMA / PMN Number
    K020935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOW MEASUREMENT CONFIRMED DURING INVESTIGATION OF THE COMPLAINT WAS ASSESSED TO POTENTIALLY POSE AS A SAFETY RISK IF IT WERE TO REOCCUR. A RECALL CLASS II HAS BEEN INITIATED AND REPORTED TO THE FDA, SEE 3003044483-07/08/2013-001-R.

    Description of Event or Problem · 1

    HEMOCUE AB RECEIVED A COMPLAINT ON HEMOCUE GLUCOSE 201 FROM A US CUSTOMER IN (B)(6). THE HEMOCUE GLUCOSE 201 MICROCUVETTES WERE REPORTED HAVING A DIFFERENT COLOR THAN USUAL AND THAT AIR BUBBLES WERE FORMED IN THE MICROCUVETTES WHEN FILLING IT WITH BLOOD. NO PT IMPACT WAS REPORTED BY CUSTOMER. DURING HEMOCUE INVESTIGATION OF COMPLAINT, IT WAS CONFIRMED THAT THE SINGLE PACK PACKAGE WAS DAMAGED AND THAT IT MAY RESULT IN LOW MEASUREMENT RESULTS OR ERROR CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435845 HEMOCUE GLUCOSE 201 MICROCUVETTES LFR: GLUCOSE TEST SYSTEM LFR HEMOCUE AB 110717 1303501

    Patients

    Seq Age Sex Outcome Treatment
    1