BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H/ ISE STD LOW 10X3ML

    MDR report key: 3775519 · Received April 28, 2014

    Report

    Report Number
    1823260-2014-03089
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    April 2, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIX
    PMA / PMN Number
    K963627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE ISSUE WAS OPERATOR HANDLING. THE STAFF MEMBER WAS UNWRAPPING THE ISE STANDARD LOW CALIBRATOR AMPULE WHEN HIS FINGER WAS CUT. THE INSTRUCTIONS FOR USE OF THE CALIBRATOR REQUIRE THE USE OF THE AMPULE IMMEDIATELY. REMAINING CONTENT MUST NOT BE STORED. OPEN AMPULES SHOULD NOT BE WRAPPED AS A NEW AMPULE IS REQUIRED FOR EVERY CALIBRATION. HE WAS WEARING GLOVES. THE STAFF MEMBER DID NOT USE GAUZE OR ANYTHING ELSE WHILE HANDLING THE OPEN AMPOULE. THE INJURY CAUSED A SUPERFICIAL LACERATION. THE STAFF MEMBER WAS NOT ADVERSELY AFFECTED BY THIS EVENT.

    Description of Event or Problem · 1

    A ROCHE STAFF MEMBER ALLEGED THEIR THUMB WAS CUT BY THE OPENED AMPOULE OF THE ISE STANDARD LOW CALIBRATOR DURING AN EVALUATION AT THE CUSTOMER'S SITE. ADDITIONAL DETAILS OF THE EVENT WERE REQUESTED BUT NOT PROVIDED. INFORMATION ON WHICH THUMB WAS CUT WAS REQUESTED BUT NOT PROVIDED. INFORMATION ON WHAT TREATMENTS THE ROCHE STAFF MEMBER RECEIVED WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255102 H/ ISE STD LOW 10X3ML CALIBRATOR, MULTI-ANALYTE MIXTURE JIX ROCHE DIAGNOSTICS NA 68106101

    Patients

    Seq Age Sex Outcome Treatment
    1 025 YR Other