BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201 MICROCUVETTES

    MDR report key: 3376866 · Received September 3, 2013

    Report

    Report Number
    3003044483-2013-00017
    Event Type
    Malfunction
    Date Received
    September 3, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    HEMOCUE AB
    Product Code
    LFR
    PMA / PMN Number
    K020935
    Removal / Correction Number
    3003044483-07/08/2013-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 HAS BEEN INITIATED AND REPORTED TO THE FDA, (B)(4). EVAL SUMMARY FOR COMPLAINT (B)(4): HEMOCUE GLUCOSE 201 ANALYZER, SERIAL NUMBER (B)(4). INVESTIGATION: GLUCOSE 201 ANALYZER: LINEARITY CHECK OF ANALYZER APPROVED, NO MALFUNCTION FOUND DURING INVESTIGATION. GLUCOSE 201 MICROCUVETTES: INVESTIGATION WAS PERFORMED ON ARCHIVED SAMPLES SINCE NO MICROCUVETTES WERE RETURNED BY THE CUSTOMER. REVIEW OF BATCH DOCUMENTATION (DHR): NOTHING REMARKABLE FOUND. FOUR PLANNED DEVIATIONS, NOT RELATED TO THE PROBLEM, WERE EFFECTIVE DURING THE TIME OF PRODUCTION OF LOT 1303517. INSPECTION OF SINGLE PACKAGES: THE SINGLE-PACKAGES FROM ARCHIVE SAMPLES WERE INSPECTED WITH REGARDS TO MARKS FROM THE KNIFE CUTTING THE DESICCANT. ALL OF THE PACKAGES KNOWN THIS MARKS. ANALYSIS OF MICROCUVETTES WITH BLOOD: MICROCUVETTES WERE ANALYZED WITH WHOLE BLOOD. SOME MICROCUVETTES ARE MEASURING TOO LOW COMPARED TO 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 ACTIONS TAKEN: REMEDIAL ACTION: THE CUSTOMER HAS BEEN REPLACED WITH CORRECT PRODUCTS AND THE AFFECTED LOT HAS BEEN WITHDRAWN FROM THE FIELD. (CORRECTION AND REMOVAL (B)(4)). 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 ACTIONS ARE HANDLED WITHIN THE HEMOCUE CAPA MANAGEMENT PROCESS.

    Description of Event or Problem · 1

    HEMOCUE AB RECEIVED A COMPLAINT ON HEMOCUE GLUCOSE 201 FROM A U.S. 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 BELOW 20 AND 30 MG/DL. NO COMPARISONS TO OTHER METHODS WERE MADE. NO PT IMPACT WAS REPORTED BY CUSTOMER. GLUCOSE 201 ANALYZER WAS RETURNED FOR INVESTIGATION BUT NO MICROCUVETTES WERE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436433 HEMOCUE GLUCOSE 201 MICROCUVETTES LFR: GLUCOSE TEST SYSTEM LFR HEMOCUE AB 110705 1303517

    Patients

    Seq Age Sex Outcome Treatment
    1