BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 TOXOPLASMA QUANT IGG

    MDR report key: 6376952 · Received March 3, 2017

    Report

    Report Number
    2432235-2017-00161
    Event Type
    Malfunction
    Date Received
    March 3, 2017
    Date of Event
    December 14, 2016
    Report Date
    April 3, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    LGD
    PMA / PMN Number
    K962936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2017-00161 WAS FILED ON MARCH 3, 2017. ADDITIONAL INFORMATION (03/06/2017): A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE DATA PROVIDED BY THE CUSTOMER. THE CUSTOMER RAN 172 NON-REACTIVE SAMPLES WITH KIT LOT 425 THEREFORE, HAVING A SPECIFICITY OF APPROXIMATELY 99.4% (172/173). THE SPECIFICITY CLAIMS AS PER IMMULITE 2000 TOXOPLASMA IGG INSTRUCTIONS FOR USE HAVE 95% CONFIDENCE LIMITS RANGING BETWEEN 94.2% - 100%. BASED ON THE DATA PROVIDED BY THE CUSTOMER, IMMULITE 2000 TOXOPLASMA IGG KIT LOT 425 IS MEETING THE SPECIFICITY CLAIMS PROVIDED IN THE INSTRUCTIONS FOR USE. THE DEVICE IS PERFORMING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCORDANT, FALSE REACTIVE TOXOPLASMA IGG RESULT ON ONE PATIENT SAMPLE IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A DISCORDANT, FALSE REACTIVE IGG ANTIBODIES TO TOXOPLASMA GONDII (TOXOPLASMA IGG) RESULT ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT, WHILE USING KIT LOT 425. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE SAMPLE WAS SENT TO AN ALTERNATE LABORATORY WHERE IT WAS TESTED ON AN ALTERNATE PLATFORM, RESULTING NON-REACTIVE. A NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND WAS TESTED ON THE IMMULITE 2000 INSTRUMENT USING KIT LOT 426 AND THE RESULT WAS NON-REACTIVE. THE CORRECTED RESULT OBTAINED ON THE REDRAWN SAMPLE WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE REACTIVE TOXOPLASMA IGG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158745 IMMULITE 2000 TOXOPLASMA QUANT IGG IMMULITE 2000 TOXOPLASMA QUANT IGG LGD SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 TOXOPLASMA QUANT IGG 425

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR