BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-PRO PLUS

    MDR report key: 12353418 · Received August 23, 2021

    Report

    Report Number
    1823260-2021-02428
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    August 2, 2021
    Report Date
    November 11, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    UDI-DI
    00075537257890
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN ANY MATERIALS FOR INVESTIGATION. WITHOUT THESE MATERIALS TO INVESTIGATE, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINTS REGARDING THIS ALLEGATION AND THE SPECIFIC LOT NUMBER INVOLVED WERE REVIEWED AND SHOWED NO INCREASE FOR THE AFFECTED PRODUCTION INTERVAL.

    Additional Manufacturer Narrative · 1

    THE LANCET DEVICE WAS DISCARDED. OCCUPATION WAS LAY USER/PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THE NEEDLE CAME OUT OF THE SAFE-T-PRO PLUS LANCET DEVICE. THE CUSTOMER ATTEMPTED TO REMOVE THE STERILITY CAP AND DEPTH DIAL WHEN THE NEEDLE CAME OUT OF THE LANCET DEVICE. THE CUSTOMER DID NOT TWIST THE STERILITY CAP WHEN THE LANCET CAME OUT OF THE DEVICE BUT HAD PULLED IT STRAIGHT OFF. THERE WAS NO ACCIDENTAL FINGERSTICK WITH THE SAFE-T PRO PLUS LANCET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251566 SAFE-T-PRO PLUS LANCET FMK ROCHE DIAGNOSTICS SAFE-T-PRO PLUS 41821005 00075537257890

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown