BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201 MICROCUVETTES

    MDR report key: 3177374 · Received June 12, 2013

    Report

    Report Number
    3003044483-2013-00003
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 7, 2013
    Manufacturer
    HEMOCUE AB
    Product Code
    CGA
    PMA / PMN Number
    K020935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOW MEASUREMENT REPORTED BY THE CUSTOMER WAS ASSESSED TO POTENTIAL POSE A SAFETY RISK IF IT WERE TO REOCCUR. IF FURTHER INFORMATION IS OBTAINED FROM THE INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 LOW READINGS ACROSS TWO DEVICES. THE REPORTED READINGS WERE 13, 15 AND 16 MG/DL RESPECTIVELY, NO COMPARISON TO OTHER METHODS WERE MADE. NO QUALITY CONTROLS WERE RUN BY THE CUSTOMER AND NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265423 HEMOCUE GLUCOSE 201 MICROCUVETTES GLUCOSE TEST SYSTEM CGA HEMOCUE AB 110705 1303507

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR