BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G)

    MDR report key: 6798208 · Received August 16, 2017

    Report

    Report Number
    1219913-2017-00179
    Event Type
    Malfunction
    Date Received
    August 16, 2017
    Date of Event
    June 7, 2017
    Report Date
    October 4, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LGD
    UDI-DI
    00630414208459
    PMA / PMN Number
    K102681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 1219913-2017-00179 WAS FILED ON AUGUST 16, 2017 REPORTING A POSITIVE ADVIA CENTAUR XP TOXOPLASMA IGG (TOXO G) RESULT COMPARED TO NEGATIVE RESULTS FROM OTHER METHODS. SEPTEMBER 19, 2017 - ADDITIONAL INFORMATION: SIEMENS REQUESTED THE FOLLOWING INFORMATION AND RECEIVED THE RESPONSES FROM THE CUSTOMER: TUBE TYPE: BECTON DICKINSON - TUBE WITHOUT HEPARIN OR EDTA, WITH A GEL SEPARATOR HAS THE SAMPLE BEEN TREATED WITH A HETEROPHILIC BLOCKING TUBE: NO. STAGE OF PREGNANCY; NOT AVAILABLE. LIST OF MEDICATIONS: NOT AVAILABLE. IS AT LEAST 1 ML OF SAMPLE AVAILABLE FOR INTERNAL TESTING: NO RESPONSE. SPECIFICITY WITH ADVIA CENTAUR XP TOXOPLASMA G KIT LOT 061220 CANNOT BE CALCULATED AT THIS CUSTOMER SITE BECAUSE THE NUMBER OF TESTS PERFORMED WAS NOT PROVIDED. ROOT CAUSE OF THE ELEVATED RESULT WITH THE ADVIA CENTAUR XP TOXOPLASMA G ASSAY CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED BUT IT APPEARS TO BE TYPICAL ASSAY PERFORMANCE. BASED ON THE AVAILABLE INFORMATION ADVIA CENTAUR XP TOXOPLASMA G LOT 061220 IS PERFORMING AS INTENDED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE REPRODUCIBLE POSITIVE ADVIA CENTAUR XP TOXO G RESULTS IS UNKNOWN. SIEMENS HAS ASKED FOR THE FOLLOWING ADDITIONAL INFORMATION FROM THE CUSTOMER: TUBE TYPE, ADDITIONAL TROUBLESHOOTING PERFORMED SUCH AS TREATING THE SAMPLE WITH A HETEROPHILIC BLOCKING TUBE, STAGE OF PREGNANCY AND A LIST OF MEDICATIONS THE PATIENT IS TAKING. SIEMENS HAS ALSO ASKED FOR AT LEAST 1 ML OF SAMPLE FOR INTERNAL TESTING. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES: "IN GEOGRAPHIC REGIONS THAT HAVE AN APPARENT LOW PREVALENCE OF TOXOPLASMA IGG IN ASYMPTOMATIC POPULATIONS, THE POSITIVE PREDICTIVE VALUE OF ANY ASSAY IS REDUCED DUE TO THE INCREASED POSSIBILITY THAT A POSITIVE RESULT IS ACTUALLY FALSELY POSITIVE. AS WITH ALL IN VITRO DIAGNOSTIC ASSAYS, EACH LABORATORY SHOULD DETERMINE ITS OWN REFERENCE RANGE(S) FOR THE DIAGNOSTIC EVALUATION OF PATIENT RESULTS."

    Description of Event or Problem · 1

    CUSTOMER OBSERVED A POSITIVE ADVIA CENTAUR XP TOXOPLASMA IGG (TOXO G) RESULT COMPARED TO RESULTS FROM OTHER METHODS. THE RESULT WAS SENT TO THE PHYSICIAN AND THE PHYSICIAN QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED DUE TO POSITIVE ADVIA CENTAUR XP TOXO G RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579537 ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 11947220 00630414208459

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR