BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR PROGESTERONE (PRGE)

    MDR report key: 3073621 · Received April 23, 2013

    Report

    Report Number
    1219913-2013-00074
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    July 6, 2012
    Report Date
    July 7, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JLS
    PMA / PMN Number
    K932955
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE INITIALLY DISCORDANT HIGH PATIENT RESULT AND OUT OF RANGE QUALITY CONTROL LEVEL THREE RESULT IS UNKNOWN. THE CUSTOMER OBSERVED THAT THE REAGENT PACK WAS GRAINY IN APPEARANCE AND AT THE TIME OF THE ISSUE AND MAY BE A CONTRIBUTING FACTOR. A NEW PROGESTERONE REAGENT LOT WAS REPLACED AND THE CUSTOMER OBSERVED ACCEPTABLE QUALITY CONTROL AND PATIENT RESULTS. THERE HAVE BEEN NO OTHER REPORTED CUSTOMER COMPLAINTS OF PROGESTERONE REAGENT PACKS WITH A GRAINY APPEARANCE FOR LOT 259. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) STATES THE FOLLOWING UNDER THE LOADING REAGENTS SECTION: "ENSURE THAT THE SYSTEM HAS SUFFICIENT PRIMARY AND ANCILLARY REAGENT PACKS. FOR DETAILED INFORMATION ABOUT PREPARING THE SYSTEM, REFER TO THE SYSTEM OPERATING INSTRUCTIONS OR TO THE ONLINE HELP SYSTEM. CAUTION: MIX ALL PRIMARY REAGENT PACKS BY HAND BEFORE LOADING THEM ONTO THE SYSTEM. VISUALLY INSPECT THE BOTTOM OF THE REAGENT PACK TO ENSURE THAT ALL PARTICLES ARE DISPERSED AND RESUSPENDED." THE INSTRUCTION FOR USE (IFU) STATES THE FOLLOWING UNDER THE QUALITY CONTROL SECTION: "SIEMENS HEALTHCARE DIAGNOSTICS RECOMMENDS THE USE OF COMMERCIALLY AVAILABLE QUALITY CONTROL MATERIALS WITH AT LEAST 2 LEVELS (LOW AND HIGH). A SATISFACTORY LEVEL OF PERFORMANCE IS ACHIEVED WHEN THE ANALYTE VALUES OBTAINED ARE WITHIN THE ACCEPTABLE CONTROL RANGE FOR THE SYSTEM OR WITHIN YOUR RANGE, AS DETERMINED BY AN APPROPRIATE INTERNAL LABORATORY QUALITY CONTROL SCHEME. IF THE QUALITY CONTROL RESULTS DO NOT FALL WITHIN THE EXPECTED VALUES OR WITHIN THE LABORATORY'S ESTABLISHED VALUES, DO NOT REPORT RESULTS."

    Description of Event or Problem · 1

    A FALSELY ELEVATED ADVIA CENTAUR PROGESTERONE RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO LOWER RESULTS WHEN REPEATED ON A NEW REAGENT LOT. THE CUSTOMER NOTED AN OUT OR RANGE QUALITY CONTROL LEVEL THREE RESULT AND OBSERVED THAT THE REAGENT PACK WAS GRAINY IN APPEARANCE. THE DISCORDANT SAMPLE WAS REPEATED ON A NEW REAGENT LOT AND THE RESULTS WERE REPRODUCIBLE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH ADVIA CENTAUR PROGESTERONE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173841 ADVIA CENTAUR PROGESTERONE (PRGE) PROGESTERONE JLS SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 259

    Patients

    Seq Age Sex Outcome Treatment
    1