BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX OPA SOLUTION TEST STRIPS

    MDR report key: 669063 · Received January 26, 2006

    Report

    Report Number
    2084725-2006-00020
    Event Type
    Malfunction
    Date Received
    January 26, 2006
    Date of Event
    October 21, 2005
    Report Date
    December 27, 2005
    Manufacturer
    ALBERT BROWNE, LTD.
    Product Code
    JOJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A 2 MONTH PERIOD, CUSTOMER INADVERTENTLY USED CIDEX OPA TEST STRIPS THAT EXPIRED A MONTH BEFORE TO TEST THEIR CIDEX OPA SOLUTION THAT WAS USED FOR HIGH-LEVEL DISINFECTION OF PATIENT INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX OPA SOLUTION TEST STRIPS INDICATOR, CHEMICAL STERILIZATION PROCESS JOJ ALBERT BROWNE, LTD. 20392 011310

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN