BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM TOXOPLASMA G (TOXOG)

    MDR report key: 15031213 · Received July 15, 2022

    Report

    Report Number
    1219913-2022-00222
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    June 28, 2022
    Report Date
    September 19, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LGD
    UDI-DI
    00630414600123
    PMA / PMN Number
    K012183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE OF THE UNITED STATES OBSERVED A POSITIVE(REACTIVE) ATELLICA IM 1600 TOXOPLASMA G (TOXOG) RESULT ON A SAMPLE THAT RESULTED NEGATIVE(NONREACTIVE) ON AN ALTERNATE METHOD AND WESTERN BLOT. THE ATELLICA IM TOXOPLASMA IGG (TOXO G) INSTRUCTIONS FOR USE (IFU) STATES IN THE INTERPRETATION OF RESULTS SECTION: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR 1219913-2022-00222 WAS FILED ON JULY 15, 2022. A CUSTOMER FROM OUTSIDE OF THE UNITED STATES OBSERVED A POSITIVE(REACTIVE) ATELLICA IM 1600 TOXOPLASMA G (TOXOG) RESULT ON A SAMPLE THAT RESULTED NEGATIVE(NONREACTIVE) ON AN ALTERNATE METHOD AND WESTERN BLOT. ADDITIONAL INFORMATION -JULY 21, 2022 THE INITIAL MDR STATED IT WAS UNKNOWN IF THE SYSTEM WAS SERVICED BY A THIRD PARTY. SECTION D8 HAS BEEN UPDATED TO REFLECT THAT THE SYSTEM WAS NOT SERVICED BY A THIRD PARTY. ADDITIONAL INFORMATION -AUGUST 9, 2022 THE CUSTOMER CONFIRMED THE QUALITY CONTROL WAS VALID AT THE TIME THE SAMPLE WAS TESTED. THE CUSTOMER PROVIDED THE FOLLOWING: REAGENT LOT 278 HAS BEEN USED SINCE THE JUNE 05, 2022 790 PATIENTS HAVE BEEN TESTED DURING THIS TIME WITH 55 POSITIVE RESULTS, 2 QUESTIONABLE RESULTS AND 733 NEGATIVE RESULTS. THE SAMPLE WAS TESTED WITH HBT AND NABT AND THE FOLLOWING RESULTS WERE OBTAINED: RESULT WITH TUBE HBT : TOXO G 57.0 IU/ML RESULT WITH TUBE NABT : TOXO G 52.2 IU/ML SIEMENS CONTINUES TO INVESTIGATE.

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR 1219913-2022-00222 WAS FILED ON JULY 15, 2022 AND MDR 1219913-2022-00222 SUPPLEMENTAL 1 WAS FILED ON AUGUST 23, 2022. A CUSTOMER FROM OUTSIDE OF THE UNITED STATES OBSERVED A POSITIVE (REACTIVE) ATELLICA IM 1600 TOXOPLASMA G (TOXOG) RESULT ON A SAMPLE THAT RESULTED NEGATIVE(NONREACTIVE) ON AN ALTERNATE METHOD AND WESTERN BLOT. ADDITIONAL INFORMATION: SEPTEMBER 9, 2022. A CUSTOMER HAD A PATIENT SAMPLE THAT RECOVERED REACTIVE ON ATELLICA IM (AIM) 1600 TOXOPLASMA IGG (TXOG) LOT: 278 AND NON-REACTIVE WITH ALTERNATE METHODS. THE CUSTOMER TREATED THE SAMPLE WITH HETEROPHILIC BLOCKING TUBE (HBT) AND NON-SPECIFIC ANTIBODY BLOCKING TUBE (NABT) AND THE RESULT WERE STILL REACTIVE, WHILE THE CONCENTRATION LEVELS REMAINED THE SAME. SIEMENS REVIEWED THE CUSTOMER'S CALIBRATION AND QC DATA FOR ALL LOTS AND THE DATA WAS COMPARABLE WITH RELEASE. FIELD PATIENT DATA FROM WITH TOTAL OF 620,271 RESULTS AND LOT: 278 RECOVERY IS COMPARABLE WITH THE OTHER LOTS. SIEMENS REVIEWED RELEASE DATA AND LOT: 278 MET ALL RELEASE CRITERIA AND WAS COMPARABLE TO OTHER LOTS. THE CALCULATED SPECIFICITY ON THIS ACCOUNT FOR TXOG LOT: 278 IS 99.9 %. THE TOTAL RESOLVED SPECIFICITY AS DESCRIBED IN THE ON ATELLICA IM TXOG INSTRUCTION FOR USE (IFU) 10995430_EN REV. 02, 2019-08 IS 99.6 %. THE CUSTOMER HAS NOT REPORTED ANY NEW INCIDENTS OF FALSE REACTIVE TXOG RESULTS AND THIS ISSUE IS CONSIDERED TO BE AN ISOLATED AND SAMPLE SPECIFIC INCIDENT. BASED ON THE AVAILABLE INFORMATION ATELLICA IM TOXOPLASMA G LOT: 278 IS PERFORMING AS INTENDED AND NO PRODUCT PERFORMANCE ISSUE HAS BEEN IDENTIFIED. CUSTOMER IS OPERATIONAL AND NO FURTHER ACTION IS REQUIRED. IN SECTION H6, INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED BASED ON ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    CUSTOMER OBSERVED A POSITIVE(REACTIVE) ATELLICA IM 1600 TOXOPLASMA G (TOXOG) RESULT ON A SAMPLE THAT RESULTED NEGATIVE(NONREACTIVE) ON AN ALTERNATE METHOD AND WESTERN BLOT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, REACTIVE ATELLICA IM 1600 TOXOG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046388 ATELLICA IM TOXOPLASMA G (TOXOG) TOXOPLASMA GONDII IMMUNOASSAY, LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 278 00630414600123

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female