BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) ASSAY

    MDR report key: 9720106 · Received February 18, 2020

    Report

    Report Number
    1219913-2020-00055
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 27, 2020
    Report Date
    April 27, 2020
    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 THE INITIAL MDR 1219913-2020-00055 ON FEBRUARY 18, 2020. SIEMENS FILED THE MDR 1219913-2020-00055 SUPPLEMENTAL REPORT 1 ON MARCH 27, 2020. APRIL 21, 2020 ADDITIONAL INFORMATION: THE CUSTOMER HAD A SAMPLE FROM A PREGNANT PATIENT THAT RECOVERED REACTIVE ON THE ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) LOT 250 AND NON-REACTIVE (NEGATIVE) WITH ALTERNATE METHODS. THE PATIENT HAD A NON-REACTIVE TOXO G RESULT ON THE ADVIA CENTAUR XPT IN NOVEMBER 2019, BUT IN JANUARY 2020 A NEW SAMPLE INITIALLY RECOVERED REACTIVE TOXO G RESULT AND NON-REACTIVE UPON REPEAT. ADDITIONAL SAMPLES WERE COLLECTED IN JANUARY 2020 AND CONTINUED TO RECOVER FALSE REACTIVE WITH TOXO G LOT 250 ON MULTIPLE ADVIA CENTAUR XPT SYSTEMS WHILE TOXOPLASMA M (TOXO M) WAS REPEATEDLY NON-REACTIVE. DUE TO THESE RESULTS THE PATIENT STARTED TREATMENT AND THE ADVIA CENTAUR XPT TOXO G RESULTED REACTIVE DURING THE TREATMENT PERIOD. TREATMENT WAS DISCONTINUED WHEN NON-REACTIVE RESULTS WERE RETRIEVED FROM THE ALTERNATE METHODS. SIEMENS REVIEWED THE CUSTOMER'S SAMPLE HANDLING CONDITIONS AND WERE IN ACCORDANCE WITH THE ADVIA CENTAUR XPT TOXO G INSTRUCTIONS FOR USE (IFU) (B)(4) RECOMMENDATIONS. THE CUSTOMER DID NOT PROVIDE CALIBRATION AND QUALITY CONTROL (QC) DATA BUT VERIFIED ACCEPTABLE RECOVERY. MAINTENANCE HAS BEEN UP TO DATE AND SINCE THE ISSUE WAS NOTED ONLY WITH THIS PATIENT AND IN MULTIPLE SYSTEMS, SERVICE WAS NOT DEEMED NECESSARY. A NEW SAMPLE RETRIEVED IN FEBRUARY 2020 THAT STILL RECOVERED REACTIVE (12.6 IU/ML) WITH THE ADVIA CENTAUR XPT TOXO G LOT 250 WHEN RUN NEAT AND WAS TREATED WITH HETEROPHILIC BLOCKING TUBE (HBT) AND NON-SPECIFIC ANTIBODY BLOCKING TUBE (NABT) AT THE CUSTOMER'S SITE. THE RESULT OF 10.5 IU/ML PRODUCED WITH NABT WAS CLOSE TO THE CUT OFF, WHILE THE HBT RESULT OF 16.9 IU/ML WAS STILL REACTIVE AND HIGHER THAN THE NEAT RUN. WHILE THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE REPRODUCIBLE FALSE REACTIVE TOXO G RESULTS ON THE ADVIA CENTAUR XPT SYSTEM, IT SEEMS TO BE AN ISOLATED EVENT AND PATIENT SPECIFIC INSTANCE. THE CUSTOMER WAS UNABLE TO PROVIDE THE TOTAL NUMBER OF NEGATIVE SAMPLES THE CUSTOMER HAS TESTED WITH ADVIA CENTAUR XPT TOXO G LOT 250, SO WE CANNOT CALCULATE THE SPECIFICITY THAT THE CUSTOMER IS SEEING. BASED ON THE AVAILABLE INFORMATION, THE ADVIA CENTAUR XPT TOXOPLASMA G LOT 250 IS PERFORMING AS INTENDED AND A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 1219913-2020-00052 SUPPLEMENTAL REPORT 2, MDR 1219913-2020-00053 SUPPLEMENTAL REPORT 2, AND MDR 1219913-2020-00054 SUPPLEMENTAL REPORT 2 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR ON FEBRUARY 18, 2020. MARCH 09,2020 ADDITIONAL INFORMATION: THE LABORATORY RAN A NEW SAMPLE FROM THE PATIENT WITH NABT (NON-SPECIFIC ANTIBODY BLOCKING TUBE) AND HBT (HETEROPHILIC BLOCKING TUBE) TUBES. THE TOXO G RESULTS ARE BELOW: SID: DATE AND TIME RESULT (B)(6), ON (B)(6) 2020 2:44 PM, 12.6 NEAT (NON CONCLUSIVE TEST), (B)(6), ON (B)(6) 2020 2:44 PM, 10.5 NABT, (B)(6), ON (B)(6) 2020 2:44 PM, 16.9 HBT. SIEMENS HEALTHCARE DIAGNOSTICS CONTINUES TO INVESTIGATE. MDR 1219913-2020-00052 SUPPLEMENTAL REPORT 1, MDR 1219913-2020-00053 SUPPLEMENTAL REPORT 1, AND MDR 1219913-2020-00054 SUPPLEMENTAL REPORT 1 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    SAMPLE TYPE IS DRY TUBE WITH SEPARATOR, GREINER REFERENCE (B)(4) THAT IS SPINNED FOR 15 MINUTES AT 20°, 3180 RPM. THE SIEMENS FIELD SERVICE ENGINEER (FSE) WAS NOT SENT TO THE CUSTOMER SITE BECAUSE ALL THE RESULTS OF ALL THE SAMPLES WERE CONSISTENT. THE CAUSE FOR THE DISCORDANT TOXOPLASMA G (TOXO G) RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE IFU 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 1219913-2020-00052 (SID (B)(6)), MDR 1219913-2020-00053 (SID (B)(6)), AND MDR 1219913-2020-00054 (SID (B)(6), INITIAL) WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    DISCORDANT (B)(6) ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) RESULTS WERE OBTAINED ON SAMPLES FROM THE SAME PATIENT. THE FIRST RESULT FOR THE PATIENT WAS NEGATIVE ON (B)(6) 2019 FOR SID (B)(6). ANOTHER SAMPLE (SID (B)(6)) WAS TESTED ON (B)(6) 2020 AND THE RESULT WAS POSITIVE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAMPLE SID (B)(6) WAS RERUN ON (B)(6) 2020 AND THE RESULT WAS NEGATIVE. ANOTHER SAMPLE (SID (B)(6)) WAS TESTED ON (B)(6) 2020 AND THE RESULT WAS POSITIVE. ANOTHER SAMPLE (SID (B)(6)) WAS TESTED ON (B)(6) 2020 TWICE AND THE RESULTS WERE POSITIVE. THE PATIENT SAMPLE WAS RUN ON ALTERNATE METHODS AND THE RESULTS WERE NEGATIVE. A CORRECTED REPORT WAS ISSUED. ALL THE TOXOPLASMA M RESULTS WERE NEGATIVE. THIS IS THE PATIENT'S SECOND PREGNANCY (TWIN PREGNANCY). TREATMENT WITH ROVAMYCIN STARTED ON (B)(6) AND THEN STOPPED ON (B)(6) AFTER CONFIRMATION AS NEGATIVE IGG. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOXOPLASMA G RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184428 ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) ASSAY TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 250 00630414208459

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR