BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX OPA SOLUTION TEST STRIPS (60 STRIPS/BOTTLE)

    MDR report key: 1487545 · Received August 20, 2009

    Report

    Report Number
    8021896-2009-00012
    Event Type
    Malfunction
    Date Received
    August 20, 2009
    Date of Event
    January 1, 2009
    Report Date
    July 30, 2009
    Manufacturer
    ALBERT BROWNE LTD.
    Product Code
    JOJ
    PMA / PMN Number
    K991709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A HOSPITAL OR MGR THAT THEY HAVE BEEN USING EXPIRED CIDEX OPA TEST STRIPS SINCE 07/2008. SHE REQUESTED INFO REGARDING THIS MATTER. A CUSTOMER CARE CENTER (CCC) ASSOCIATE FOLLOWED UP WITH THE CUSTOMER. THE CALLER REPORTED THAT THE CURRENT TEST STRIPS THEY ARE USING HAD EXPIRED IN APRIL OF 2009, BUT IT WAS NOT NOTICED AT THE TIME THE BOTTLE WAS OPENED. THEY CHECKED THEIR OTHER STORED TEST STRIPS AND FOUND OTHERS THAT HAD EXPIRED IN 07/2008. SHE WAS INFORMED THAT WE CANNOT RECOMMEND THE USE OF THE TEST STRIPS BEYOND THEIR EXP DATE AS WE WOULD NOT BE ABLE TO GUARANTEE THEY WOULD PERFORM PER THE PRODUCT SPECS. THE CALLER REPORTED THAT SHE HAS INVOLVED THE FACILITY INFECTION CONTROL PERSON REGARDING THIS ISSUE. AT THE TIME OF THE REPORT, THEY HAD NO INFO REGARDING THE NUMBER OF PTS OR PROCEDURES INVOLVED. IN A SUBSEQUENT TELEPHONE F/U, ANOTHER OR MGR, STATED TWO PTS WERE INVOLVED, BUT NO ADVERSE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX OPA SOLUTION TEST STRIPS (60 STRIPS/BOTTLE) BIOCIDES TEST STRIPS (JOJ) JOJ ALBERT BROWNE LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA