BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201 MICROCUVETTES

    MDR report key: 3347550 · Received August 21, 2013

    Report

    Report Number
    3003044483-2013-00009
    Event Type
    Malfunction
    Date Received
    August 21, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    HEMOCUE AB
    Product Code
    LFR
    PMA / PMN Number
    K020935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOW MEASUREMENT REPORTED BY THE CUSTOMER WAS ASSESSED TO POTENTIALLY POSE A SAFETY RISK IF IT WERE TO RE-OCCUR. 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. THE HEMOCUE GLUCOSE 201 SYSTEM WAS REPORTED GETTING DIFFERENT READINGS DURING PT TESTING. THE REPORTED READINGS WERE 30 COMPARED TO 87, 37 COMPARED TO 87, 17 COMPARED TO 76, AND 30 COMPARED TO 98 MG/DL (FIRST SAMPLE COMPARED TO SECOND SAMPLE ON SAME PT). NO COMPARISONS TO OTHER METHODS WERE MADE. QUALITY CONTROLS WERE REPORTED TO BE WITHIN RANGE. NO PT IMPACT WAS REPORTED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406870 HEMOCUE GLUCOSE 201 MICROCUVETTES LFR: GLUCOSE TEST SYSTEM LFR HEMOCUE AB 110705 1303505

    Patients

    Seq Age Sex Outcome Treatment
    1