BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMP

    MDR report key: 2999459 · Received March 8, 2013

    Report

    Report Number
    1119779-2013-00002
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    December 22, 2012
    Report Date
    January 22, 2013
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    MKZ
    PMA / PMN Number
    K081824
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IS A LONG TIME USER OF THE SYSTEM. THE FACILITY HAS RECEIVED TRAINING PRIOR TO USING THE SYSTEM. THIS ISSUE APPEARS TO BE ISOLATED TO A NEW TECH IN THE LABORATORY. THE SYSTEM CONTAINS VARIOUS WARNINGS TO HELP PREVENT CUSTOMERS FROM SETTING THE TEST UP IN AN INCORRECT LAYOUT. THE CUSTOMER RECEIVES TRAINING PRIOR TO USE WHICH INCLUDES HOW TO POPULATE THE WELLS. DOCUMENTATION IS PRESENT IN MULTIPLE RESOURCES THAT THE CUSTOMER HAS AT THEIR TESTING SITE INCLUDING: VIPER TRAINING MANUAL, VIPER INSTRUMENT USER'S MANUAL, VIPER QUICK REFERENCE GUIDE. THE MICROWELLS ARE COLOR CODED, (B)(6) IS GREEN/PURPLE AND (B)(6) IS YELLOW/PURPLE. THE COLOR CODING ALSO VISIBLY DISPLAYED IN THE PROPER ORDER ON THE MONITOR WHEN THE USER IS SETTING UP THE RUN. COMPLAINT HISTORY WAS EVALUATED AND THIS IS AN ISOLATED INCIDENT. THERE IS NO TREND AND NO OTHER COMPLAINTS OF THIS NATURE. THE END USER AT THE SITE WILL BE RETRAINED. QUALITY WILL CONTINUE TO MONITOR FOR THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    THE PROBETEC QX SYSTEM IS USED TO TEST PATIENT SAMPLES FOR THE PRESENCE OF (B)(6). DURING THE SET-UP OF THE MICRO-WELLS FOR A (B)(6) RUN, THE END-USER INCORRECTLY PLACED THE (B)(6) WELL STRIPS IN REVERSE ORDER, THEREBY A POSITIVE CT RESULT WAS ACTUALLY A (B)(6) RESULT AND VICE VERSA. THIS OCCURRED OVER 3 RUNS BY THE SAME END USER. ALL PATIENTS HAD TO BE RE-CALLED AND INFORMED THAT THEY HAD BEEN MISDIAGNOSED. (B)(6). PATIENT OUTCOME: (B)(4) PATIENTS WITH NO INFECTION, TREATED UNNECESSARILY FOR (B)(6). SIX PATIENTS TREATED APPROPRIATELY FOR (B)(6) BECAUSE OF (B)(6) RESULTS BUT IN ADDITION WERE POTENTIALLY TREATED UNNECESSARILY FOR (B)(6) DEPENDANT ON CLINIC PROTOCOLS. (B)(4) PATIENTS NOT TREATED APPROPRIATELY FOR (B)(6) (BUT TREATED FOR (B)(6)) DEPENDANT ON CLINIC PROTOCOLS. (B)(4) PATIENTS NOT TREATED APPROPRIATELY FOR (B)(6) (BUT TREATED FOR (B)(6)) DEPENDANT ON CLINIC PROTOCOLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100412 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMP MKZ BD DIAGNOSTIC SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other