BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201 MICROCUVETTES

    MDR report key: 3221823 · Received July 8, 2013

    Report

    Report Number
    3003044483-2013-00007
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 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 POTENTIAL POSE A SAFETY RISK IF IT WERE TO REOCCUR. A RECALL CLASS II IS IN PROCESS OF BEING SUBMITTED AND REPORTED TO THE FDA (THE REFERENCE NUMBER WILL BE 3003044483-07/08/2013-001-R). EVAL SUMMARY FOR COMPLAINT (B)(4). HEMOCUE GLUCOSE 201 MICROCUVETTES, LOT 1303787. INVESTIGATION: REVIEW OF BATCH DOCUMENTATION (DHR): NOTHING REMARKABLE FOUND. TWO PLANNED DEVIATIONS, NOT RELATED TO THE PROBLEM, WERE EFFECTIVE DURING THE TIME OF PRODUCTION OF LOT 1303787. INSPECTION OF SINGLE PACKAGES: THE SINGLE-PACKAGES WERE INSPECTED WITH REGARDS TO MARKS FROM THE KNIFE CUTTING THE DESICCANT. ALL OF THE PACKAGES SHOWN THIS MARKS. VISUAL INSPECTION OF MICROCUVETTES: SOME MICROCUVETTES HAD DIFFERENT DRYING PATTERN. ANALYSIS OF MICROCUVETTES WITH BLOOD: MICROVUVETTES WERE ANALYZED WITH WHOLE BLOOD. SOME MICROCUVETTES ARE MEASURING TOO LOW COMPARED REFERENCE CUVETTES. CONCLUSION: THE MALFUNCTION FOUND IS DAMAGED SINGLE PACK POUCHES RELATED TO THE PRODUCTION PROCESS. DAMAGED SINGLE PACK POUCHES MAY CAUSE VERY LOW GLUCOSE RESULTS IF POUCHES ARE EXPOSED TO MOISTURE. ACTIONS TAKEN: REMEDIAL ACTION: THE CUSTOMER HAS BEEN REPLACED WITH CORRECT PRODUCTS AND THE AFFECTED LOT WILL BE WITHDRAWN FROM THE FIELD. (CORRECTION AND REMOVAL 3003044483-07/08/2013-001-R). CORRECTION: A DESIGN CHANGE WAS IMPLEMENTED IN THE PRODUCTION PROCESS CONSISTING OF A "MECHANICAL RESISTANCE WHEN CUTTING THE DESICCANT IN THE SINGLE PACKAGING PROCESS. CORRECTIVE AND PREVENTIVE ACTONS ARE HANDLED WITHIN THE HEMOCUE CAPA MANAGEMENT PROCESS.

    Description of Event or Problem · 1

    HEMOCUE (B)(4) RECEIVED A COMPLAINT ON HEMOCUE GLUCOSE 201 FROM A US CUSTOMER. THE HEMOCUE GLUCOSE 201 SYSTEM WAS REPORTED GETTING LOW READING ON PT TESTING. THE REPORTED READINGS WERE 30 TO 90 MG/DL AND NO COMPARISONS TO OTHER METHODS WERE MADE. QUALITY CONTROLS WERE REPORTED TO BE OUT OF RANGE. NO PT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309082 HEMOCUE GLUCOSE 201 MICROCUVETTES LFR: GLUCOSE TEST SYSTEM LFR HEMOCUE AB 110705 1303787

    Patients

    Seq Age Sex Outcome Treatment
    1