BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVIA CENTAUR TOXOPLASMA M (TOXO M)

    MDR report key: 2799892 · Received October 22, 2012

    Report

    Report Number
    1219913-2012-00378
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 26, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LGD
    PMA / PMN Number
    K010755
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ADDITIONAL INFORMATION: THE PATIENT SAMPLE WAS PROVIDED TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER INVESTIGATION. THE SAMPLE WAS IN POOR CONDITION WITH SIGNIFICANT PARTICULATE MATTER. THE SAMPLE WAS RECENTRIFUGED AND TESTED ON REAGENT LOTS 080223, 080224 AND 080226. THE RESULTS WERE 2.40 INDEX, 2.00 INDEX, AND 2.96 INDEX RESPECTIVELY WHICH CONFIRMS THAT THE ISSUE IS NOT SITE SPECIFIC AND NOT REAGENT LOT SPECIFIC. NO OTHER KNOWN DISCORDANT ADVIA CENTAUR XP TOXOPLASMA M PATIENT RESULTS WERE REPORTED AT THE TIME OF THE EVENT. SPECIMEN COLLECTION AND HANDLING MAY BE A CONTRIBUTING FACTOR FOR THE DISCORDANT RESULT. THE INFORMATION FOR USE (IFU) IN THE SPECIMEN COLLECTION AND HANDLING SECTION: BEFORE PLACING SAMPLES ON THE SYSTEM, ENSURE THAT THE SAMPLES HAVE THE FOLLOWING CHARACTERISTICS: SAMPLES ARE FREE OF FIBRIN OR OTHER PARTICULATE MATTER. REMOVE PARTICULATES BY FILTRATION OR CENTRIFUGATION AT 1000 X G FOR 10 TO 15 MINUTES." THE INFORMATION FOR USE (IFU) IN THE INTERPRETATION OF RESULTS SECTION: POSITIVE FOR TOXO M, NEGATIVE FOR TOXO G: "OBTAIN A NEW SPECIMEN FOR FURTHER TESTING. THE PATIENT MAY OR MAY NOT BE ACUTELY INFECTED WITH T. GONDII. SINCE THE IGG ANTIBODIES TO T. GONDII ARE NEGATIVE, THE SPECIMEN MAY HAVE BEEN OBTAINED TOO EARLY IN THE DISEASE PROCESS FOR AN ACCURATE DETERMINATION. RETEST THE NEW SPECIMEN WITH A DIFFERENT ANTI-T. GONDII IGM ASSAY. IF THE NEW SPECIMEN RESULT IS STILL POSITIVE FOR IGM ANTIBODIES, THE SPECIMEN SHOULD BE SENT TO A REFERENCE LABORATORY WITH EXPERIENCE IN THE DIAGNOSIS OF TOXOPLASMOSIS FOR FURTHER TESTING. "

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR ON (B)(4) 2012. (B)(4) 2012: ADDITIONAL INFORMATION: SIEMENS HEALTHCARE DIAGNOSTICS RECEIVED PATIENT CLINICAL INFORMATION. THE DELIVERY OCCURRED ON (B)(6) 2012. THE PATIENT WAS AT (B)(6). THE DELIVERY WAS NORMAL AND NO MEDICATION WAS GIVEN. THE PATIENT'S CONDITION WAS NORMAL AND THE INFANT'S CONDITION UPON DELIVERY WAS NORMAL. THE INFORMATION FOR USE (IFU) IN THE INTERPRETATION OF RESULTS SECTION: POSITIVE FOR TOXO M, NEGATIVE FOR TOXO G: "OBTAIN A NEW SPECIMEN FOR FURTHER TESTING. THE PATIENT MAY OR MAY NOT BE ACUTELY INFECTED WITH T. GONDII. SINCE THE IGG ANTIBODIES TO T. GONDII ARE NEGATIVE, THE SPECIMEN MAY HAVE BEEN OBTAINED TOO EARLY IN THE DISEASE PROCESS FOR AN ACCURATE DETERMINATION. RETEST THE NEW SPECIMEN WITH A DIFFERENT ANTI-T. GONDII IGM ASSAY. IF THE NEW SPECIMEN RESULT IS STILL POSITIVE FOR IGM ANTIBODIES, THE SPECIMEN SHOULD BE SENT TO A REFERENCE LABORATORY WITH EXPERIENCE IN THE DIAGNOSIS OF TOXOPLASMOSIS FOR FURTHER TESTING. "

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP TOXOPLASMA M RESULT IS UNKNOWN. PATIENT'S CLINICAL INFORMATION IS UNAVAILABLE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. THE IFU STATES IN THE LIMITATIONS SECTION: "PATIENT SPECIMENS COLLECTED VERY EARLY DURING THE ACUTE PHASE OF INFECTION MAY CONTAIN TOXOPLASMA IGM LEVELS BELOW THE CUTOFF OF THE ADVIA CENTAUR TOXOPLASMA M ASSAY. ADDITIONALLY, DIAGNOSIS OF A RECENT INFECTION SHOULD NOT BE MADE BASED ON A SINGLE SAMPLING BECAUSE IGM ANTIBODIES TO T. GONDII MAY PERSIST IN SERUM MANY MONTHS AFTER INFECTION. THE PRESENCE OF IGM ANTIBODIES TO T. GONDII IS NOT DIAGNOSTIC FOR RECENT INFECTION."

    Description of Event or Problem · 1

    A POSITIVE ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO AN ALTERNATE TEST METHOD. THE REPEAT PATIENT SAMPLE RESULT WAS POSITIVE. THE OBSTETRICIAN DELIVERED THE INFANT BEFORE TERM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR TOXOPLASMA M (TOXO M) TOXO M IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 219

    Patients

    Seq Age Sex Outcome Treatment
    1 Other