BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENATUR XPT TOXOPLASMA G (TOXO G)

    MDR report key: 10677643 · Received October 14, 2020

    Report

    Report Number
    1219913-2020-00336
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    June 5, 2020
    Report Date
    January 21, 2021
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED INITIAL MDR 1219913-2020-00336 ON OCTOBER 4, 2020. CORRECTION FROM 11/15/2020: ALTHOUGH THE EVENT (FALSE POSITIVE RESULTS) HAS NOT CHANGED, THE INFORMATION PROVIDED IN SECTIONS B3 (DATE OF EVENT) AND B6 (RELEVANT TESTS / LABORATORY DATA) OF INITIAL MDR 1219913-2020-00336 IS BEING UPDATED BASED ON UPDATED INFORMATION PROVIDED IN THE COMPLAINT ON 11/15/2020. PLEASE REFERENCE SECTIONS B3 AND B6 OF THIS SUPPLEMENTAL REPORT FOR THE UPDATED INFORMATION. ADDITIONAL INFORMATION FROM 11/15/2020: THE CUSTOMER PERFORMED HBT AND NABT TESTING. SIEMENS REVIEWED THE RESULTS. FROM THE DATA PROVIDED, IT SEEMS THAT THE VALUE DROPPED POST HBT / NABT TESTING, BUT STILL RECOVERED REACTIVE. THERE COULD BE SOME INTERFERENT CAUSING THE FALSE REACTIVE RESULTS TO THIS PATIENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION TO CONTINUE INVESTIGATION. MDR 1219913-2020-00337 WAS FILED FOR THE DISCORDANT REACTIVE RESULT OBTAINED ON SAMPLE (B)(4) USING LOT: 261. MDR 1219913-2020-00338 WAS FILED FOR THE DISCORDANT REACTIVE RESULT OBTAINED ON SAMPLE (B)(4) USING LOT: 259.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED INITIAL MDR 1219913-2020-00336 ON OCTOBER 14, 2020 AND MDR 1219913-2020-00336 SUPPLEMENTAL 1 REPORT ON DECEMBER 10, 2020. ADDITIONAL INFORMATION: 12/29/2020. SIEMENS HAS CONCLUDED THE INVESTIGATION FOR FALSE POSITIVE RESULTS ON DIFFERENT SAMPLES FROM THE SAME PATIENT USING ADVIA CENTAUR XP TOXOPLASMA IGG (TOXO G) COMPARED TO THE NON-REACTIVE RESULT OBTAINED WITH ALTERNATE TEST METHODS. THE PATIENT WAS ALSO TESTED FOR TOXOPLASMA IGM AND RESULTED NON-REACTIVE. SIEMENS REVIEWED THE CUSTOMER'S CALIBRATION DATA AND IT WAS COMPARABLE TO INTERNAL RELEASE DATA. QUALITY CONTROL RECOVERED WITHIN RANGES. SAMPLE HANDLING WAS IN ACCORDANCE WITH ADVIA CENTAUR XP TOXO G INSTRUCTIONS FOR USE (IFU). SIEMENS RETRIEVED SIEMENS ANALYTICS SERVICE (SAS) PATIENT DATA FROM FEBRUARY 2019 TO JUNE 2020 THAT INCLUDED TOXO G LOTS: 246-261, AND LOT: 259 RECOVERED SIMILARLY FOR INTERPRETATION OF RESULT RATES WITH THE PREVIOUS LOTS. SIEMENS INITIATED AN INTERNAL STUDY THAT INCLUDED ATELLICA IM (AIM) TOXO G LOTS: 252, 258, 260 AND 262, FIFTY (50) NORMAL PATIENT SAMPLES FROM SIEMENS AND FIFTY (50) PATIENT SAMPLES FROM FRANCE. THE PATIENT SAMPLES FROM FRANCE FOR THE INTERNAL STUDY WERE PURCHASED BY SIEMENS FROM AN APPROVED SUPPLIER AND FRENCH ACQUISITION COMPANY (INOSPECIMENS NIOBANK). AIM TOXO G LOT: 252 IS THE SAME AS ADVIA CENTAUR SYSTEMS TOXO G LOT: 253, AIM LOT: 258 IS THE SAME AS ADVIA CENTAUR SYSTEMS LOT: 259, AIM LOT: 260 IS THE SAME AS ADVIA CENTAUR SYSTEMS LOT: 261 AND AIM LOT: 262 IS THE SAME AS ADVIA CENTAUR SYSTEMS LOT: 263. THE REAGENT COMPONENTS ARE THE SAME, HENCE A SIMILAR TREND IN THE AIM STUDY RESULTS IS EXPECTED TO BE PRODUCED WITH ADVIA CENTAUR SYSTEMS LOTS. ALL SAMPLES WERE TESTED IN REPLICATES OF 3 (N=3) AND THE FINAL INTERPRETATION WAS THE SAME FOR ALL PATIENT SAMPLES ACROSS ALL REAGENT LOTS, WITH THE EXCEPTION OF 1 MANUFACTURING SAMPLE. THE CUSTOMER TREATED THE SAMPLE WITH HETEROPHILIC BLOCKING TUBE (HBT) AND NON-SPECIFIC ANTIBODY BLOCKING TUBE (NABT). THE TOXO G VALUES WERE LOWER, BUT STILL RECOVERED REACTIVE. BASED ON THE AVAILABLE INFORMATION, THE REPRODUCIBLE FALSE REACTIVE ADVIA CENTAUR XP TOXO G RESULTS ARE NOT SPECIFIC TO A REAGENT LOT OR SAMPLE/DRAW. IT SEEMS THAT SOME TYPE OF INTERFERENT SPECIFIC TO THIS PATIENT COULD BE THE CAUSE. THE TOTAL NUMBER OF NEGATIVE SAMPLES THE CUSTOMER HAS TESTED WITH ADVIA CENTAUR XP TOXO G LOT: 259 AND/OR 261 WERE NOT PROVIDED, THEREFORE THE SPECIFICITY COULD NOT BE CALCULATED. BASED ON THE INVESTIGATION RESULTS, ADVIA CENTAUR XP TOXOPLASMA IGG IS PERFORMING AS INTENDED AND A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. CUSTOMER IS OPERATIONAL. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND CONCLUSION CODES HAVE BEEN UPDATED TO REFLECT THE INVESTIGATION RESULTS. REFERENCE SECTION H6 OF THIS REPORT FOR THE FINAL CODES FOR THIS EVENT. MDR 1219913-2020-00337 SUPPLEMENTAL 2 REPORT WAS FILED FOR THE DISCORDANT REACTIVE RESULT OBTAINED ON SAMPLE (B)(4) USING LOT: 261. MDR 1219913-2020-00338 SUPPLEMENTAL 2 REPORT WAS FILED FOR THE DISCORDANT REACTIVE RESULT OBTAINED ON SAMPLE (B)(4) USING LOT: 259.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE SYSTEM CALIBRATIONS AND QUALITY CONTROL (QC) RESULTS WERE VALID. THE TOXO G INSTRUCTIONS FOR USE STATES IN THE LIMITATIONS SECTION: "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." MDR 1219913-2020-00337 WAS FILED FOR THE DISCORDANT REACTIVE RESULT OBTAINED ON SAMPLE 102026104410 USING LOT 259. MDR 1219913-2020-00338 WAS FILED FOR THE DISCORDANT REACTIVE RESULT OBTAINED ON SAMPLE 102026104410 USING LOT 263.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED REACTIVE (POSITIVE) RESULTS ON TWO SAMPLES FROM THE SAME PATIENT USING THE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY. THESE RESULTS WERE CONSIDERED DISCORDANT COMPARED TO THE NON-REACTIVE (NEGATIVE) RESULTS OBTAINED WHEN THE SAMPLES WERE TESTED USING ALTERNATE METHODS. THE FIRST PATIENT SAMPLE WAS SENT TO AN ALTERNATE LABORATORY AND PROCESSED ON AN ALTERNATE METHOD; A NEGATIVE RESULT WAS OBTAINED. THE SECOND SAMPLE WAS ALSO SENT OUT AND PROCESSED ON AN ALTERNATE METHOD; A NEGATIVE RESULT WAS OBTAINED. THE POSITIVE ADVIA CENTAUR XP TOXO G RESULTS WERE REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. IT IS UNKNOWN IF A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE TOXO G RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143172 ADVIA CENATUR XPT TOXOPLASMA G (TOXO G) TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 259 00630414208459

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR