BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201 MICROCUVETTES

    MDR report key: 3379363 · Received September 3, 2013

    Report

    Report Number
    3003044483-2013-00020
    Event Type
    Malfunction
    Date Received
    September 3, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 5, 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
    AZ, 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, SEE 3003044483-07/08/2013-001-R. INVESTIGATION: INVESTIGATION WAS PERFORMED ON ARCHIVED SAMPLES SINCE NO MICROCUVETTES WERE RETURNED BY THE CUSTOMER. REVIEW OF BATCH DOCUMENTATION (DHR): NOTHING REMARKABLE FOUND. THREE PLANNED DEVIATIONS, NOT RELATED TO THE PROBLEM, WERE EFFECTIVE DURING THE TIME OF PRODUCT OF LOT 1303786. 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 SHOWN THESE 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 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 ACTIONS TAKEN: REMEDIAL ACTION: THE CUSTOMER HAS BEEN REPLACED WITH CORRECT PRODUCTS AND THE AFFECTED LOT HAS BEEN WITHDRAWN FROM THE FIELD (CORRECTION AND REMOVAL 3003044483-07/08/2013-001-R). CORRECTION: A DESIGN CHANGE WAS IMPLEMENTED IN THE PRODUCT 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 US CUSTOMER. THE HEMOCUE GLUCOSE 201 SYSTEM WAS REPORTED GETTING LOW READINGS DURING PT TESTING. THE READING RESULTS GIVEN BY THE CUSTOMER WERE 15 AND 19 MG/DL. NO COMPARISONS TO OTHER METHODS WERE MADE. QUALITY CONTROLS WERE WITHIN RANGE. NO PT IMPACT WAS REPORTED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434981 HEMOCUE GLUCOSE 201 MICROCUVETTES LFR: GLUCOSE TEST SYSTEM LFR HEMOCUE AB 110705 1303786

    Patients

    Seq Age Sex Outcome Treatment
    1