BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201 MICROCUVETTES

    MDR report key: 3379405 · Received September 3, 2013

    Report

    Report Number
    3003044483-2013-00023
    Event Type
    Malfunction
    Date Received
    September 3, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    HEMOCUE AB
    Product Code
    LFR
    PMA / PMN Number
    K020935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOW MEASUREMENT REPORTED BY THE CUSTOMER 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. THE HEMOCUE GLUCOSE 201 SYSTEM WAS REPORTED GETTING LOW READINGS DURING PT TESTING AND QUALITY CONTROL. THE READING RESULTS GIVEN BY THE CUSTOMER WERE 30, 70 AND 90 MG/DL. NO COMPARISONS TO OTHER METHODS WERE MADE. NO PT IMPACT WAS REPORTED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436328 HEMOCUE GLUCOSE 201 MICROCUVETTES LFR: GLUCOSE TEST SYSTEM LFR HEMOCUE AB 110705 1303786

    Patients

    Seq Age Sex Outcome Treatment
    1