BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SOFTCLIX

    MDR report key: 6861949 · Received September 13, 2017

    Report

    Report Number
    1823260-2017-01970
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Date of Event
    August 24, 2017
    Report Date
    November 1, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    9 UNUSED ACCU-CHEK SOFTCLIX LANCETS OF UNKNOWN LOT NUMBER AND 1 UNUSED ACCU-CHEK AUTOCLIX LANCET OF UNKNOWN LOT NUMBER WERE RETURNED FOR INVESTIGATION. NO LANCING DEVICE WAS RETURNED. THE RETURNED SOFTCLIX LANCETS WERE TESTED WITH A TEST ACCU-CHEK SOFTCLIX LANCING DEVICE AT 11 DIFFERENT PRICKING DEPTH SETTINGS. FOR EACH ATTEMPT, THE NEEDLE WAS CORRECTLY RETRACTED, EJECTED, AND PRODUCED A PUNCTURE HOLE. NO MALFUNCTION COULD BE OBSERVED. NO FURTHER INVESTIGATION IS POSSIBLE SINCE THE COMPLAINED LANCING DEVICE WAS NOT RETURNED. THE TESTED LANCETS WERE OBSERVED WITH A MICROSCOPE AND NO ABNORMALITIES RELATED TO THE CUSTOMER ALLEGATION COULD BE OBSERVED. THE MEDICAL RISK ASSOCIATED WITH THE CUSTOMER ISSUE IS VERY REMOTE OR LESS THAN REMOTE.

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING AN ISSUE WITH THEIR COAGUCHEK XS METER, THE PATIENT LOADED A NEW NEEDLE INTO AN ACCU-CHEK SOFTCLIX LANCET DEVICE. THE PATIENT ACCIDENTALLY STUCK HERSELF WITH THE NEEDLE SINCE THE LANCET NEEDLE WAS STICKING OUT BEYOND THE CAP OF THE DEVICE. THE PATIENT DID NOT PRESS THE BUTTON USED TO TRIGGER THE NEEDLE WHEN THE EVENT OCCURRED. THE LANCET APPEARED TO BE SEATED CORRECTLY WHEN THE CAP WAS REMOVED. THE PATIENT DID NOT SEEK MEDICAL TREATMENT. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE PATIENT'S PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION. THE PATIENT DID NOT WANT ANY REPLACEMENT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642764 ACCU-CHEK SOFTCLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA #?

    Patients

    Seq Age Sex Outcome Treatment
    1