BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX OPA SOLUTION TEST STRIPS

    MDR report key: 1456180 · Received May 28, 2009

    Report

    Report Number
    8021896-2009-00011
    Event Type
    Malfunction
    Date Received
    May 28, 2009
    Report Date
    April 30, 2009
    Manufacturer
    ALBERT BROWNE LTD.
    Product Code
    JOJ
    PMA / PMN Number
    K991709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    GENDER: NA. DATE OF EVENT: UNK. (B) (4) : DEVICE, INCORRECT CARE/USE OF.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT CIDEX OPA TEST STRIPS WHICH EXPIRED ABOUT 2008-01 HAD BEEN USED FOR 90 DAYS. WHEN THIS WAS DISCOVERED, THE BOTTLE OF TEST STRIPS WAS DISCARDED AND A NEW BOTTLE WAS OPENED WITH AN EXPIRATION DATE LATER THIS YEAR. THE CALLER REPORTED THAT THEY CHANGE THE CIDEX OPA SOLUTION EVERY 14 DAYS AND INQUIRED IF THIS WAS ALRIGHT. SHE WAS INFORMED THAT EVEN IF THE SOLUTION WAS CHANGED EVERY 14 DAYS, ASP CANNOT RECOMMENDED USE OF TEST STRIP TO TEST THE SOLUTION. IF THE PRODUCT IS EXPIRED ASP CANNOT GUARANTEE THAT THE PRODUCT IS WITHIN SPECIFICATIONS AND ANY RESULTS OBTAINED WOULD NOT BE ACCURATE. SHE WAS ADVISED TO DISCUSS WITH THEIR FACILITY INFECTION CONTROL ABOUT THE APPROPRIATE ACTION TO TAKE REGARDING THIS MATTER. SUBSEQUENTLY, DURING A TELEPHONE FOLLOW-UP, WHEN ASKED ABOUT ANY PT INVOLVEMENT WITH RESPECT TO THE EXPIRED PRODUCT, THE CALLER STATED THAT SHE WAS NOT AWARE OF ANY PT ADVERSE EVENT. THEY NOW USE PRODUCTS THAT ARE WITHIN THEIR EXPIRATION DATING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA