BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK SOFTCLIX

    MDR report key: 20609879 · Received November 5, 2024

    Report

    Report Number
    1823260-2024-03193
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 10, 2024
    Report Date
    January 6, 2025
    Manufacturer
    BALDA MEDICAL GMBH & CO. KG
    Product Code
    FMK
    UDI-DI
    07613336173046
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4 WAS UPDATED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE COAGUCHEK SOFTCLIX LANCETS LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE REPORTER'S SOFTCLIX DEVICE AND LANCETS WERE REQUESTED FOR THE INVESTIGATION, HOWEVER, THE BOX OF THE SOFTCLIX LANCETS IS NO LONGER AVAILABLE. A REPLACEMENT FOR THE SOFTCLIX DEVICE AND A SAMPLE PACK OF THE SOFTCIX LANCETS WERE SENT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    SECTIONS D4 AND D9 WERE UPDATED. THE COAGUCHEK XS SOFTCLIX LANCING DEVICE WAS RECEIVED FOR INVESTIGATION. THE LANCING DEVICE WAS TESTED WITH TEST LANCETS INTO A RUBBER MAT AT 11 DIFFERENT PRICKING DEPTH SETTINGS, FOR EACH ATTEMPTED NEEDLE WAS CORRECTLY RETRACTED, EJECTED, AND PRODUCED A PUNCTURE HOLE. THE LANCING DEVICE COULD BE PRIMED AND RELEASED WITHOUT ANY PROBLEMS AND AFTER INSERTING THE LANCET AND INSTALLING THE CAP NO NEEDLE WAS PRODUCED. THE LANCING DEVICE WAS DISASSEMBLED FOR INVESTIGATION AND NO ABNORMALITIES WERE OBSERVED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION THAT A PROPERLY SEATED COAGUCHEK XS SOFTCLIX LANCET PROTRUDES FROM THE CORRECTLY POSITIONED END CAP WHEN THE CORRECT LANCET IS USED ON THE COAGUCHEK XS SOFTCLIX DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611264 COAGUCHEK SOFTCLIX BLOOD LANCET FMK BALDA MEDICAL GMBH & CO. KG BAY094 07613336173046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown