BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201 MICROCUVETTES

    MDR report key: 3570584 · Received November 13, 2013

    Report

    Report Number
    3003044483-2013-00025
    Event Type
    Malfunction
    Date Received
    November 13, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    HEMOCUE AB
    Product Code
    LFR
    PMA / PMN Number
    K20935
    Removal / Correction Number
    3003044483-07/08/2013-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOW MEASUREMENT REPORTED BY THE CUSTOMER WAS ASSESSED TO POTENTIALLY POSE A SAFETY RISK IF IT WAS TO REOCCUR. A RECALL CLASS II HAS BEEN INITIATED AND REPORTED TO THE FDA, SEE 3003044483-001-R. INVESTIGATION: INVESTIGATION WAS PERFORMED ON SAMPLES RETURNED BY THE CUSTOMER. 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 1303508. 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 ACTIONS TAKEN: REMEDIAL ACTION: THE CUSTOMER HAS BEEN REPLACED WITH CORRECT PRODUCTS AND THE AFFECTED LOT HAS BEEN WITHDRAWN FROM THE FIELD.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 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 ACTIONS ARE HANDLED WITHIN THE HEMOCUE CAPA MANAGEMENT PROCESS.

    Description of Event or Problem · 1

    HEMOCUE AB RECEIVED A COMPLAINT ON HEMOCUE GLUCOSE 201 SYSTEM FROM A US CUSTOMER. THE HEMOCUE GLUCOSE 201 SYSTEM WAS REPORTED GETTING LOW READINGS DURING RUNNING OF CONTROLS. THE RESULTS REPORTED BY THE CUSTOMER WERE DESCRIBED AS EXTREMELY LOW. THERE WAS NO COMPARISON TO OTHER METHODS. NO PATIENT IMPACT WAS REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588588 HEMOCUE GLUCOSE 201 MICROCUVETTES GLUCOSE TEST SYSTEM LFR HEMOCUE AB 11075 1303508

    Patients

    Seq Age Sex Outcome Treatment
    1