BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINGERSTIX LANCETS/LANCETTES

    MDR report key: 35056 · Received July 21, 1996

    Report

    Report Number
    35056
    Event Type
    Malfunction
    Date Received
    July 21, 1996
    Date of Event
    July 12, 1996
    Report Date
    July 18, 1996
    Manufacturer
    MILES, INC.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    NURSE PUT LANCET ON DEVICE AND ATTEMPTED TO DO A BLOOD SUGAR CHECK. THE TOP BUTTON WOULD NOT DEPRESS AND AS SHE EXAMINED IT, THE TOOL POKED HER DIGIT OF HER (L) HAND, BROKE THE SKIN. AFTER DISCOVERING THIS, OBSERVED THAT LANCET HAD BROKEN RESIDENT'S SKIN AND DREW BLOOD.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: DEVICE FAILURE INDIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINGERSTIX LANCETS/LANCETTES FINGERSTIX LANCETS/LANCETTES FMK MILES, INC. NDC 0193-5965-31 9613113

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other