BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    MDR report key: 6914494 · Received October 4, 2017

    Report

    Report Number
    1219913-2017-00214
    Event Type
    Malfunction
    Date Received
    October 4, 2017
    Date of Event
    August 23, 2017
    Report Date
    November 28, 2017
    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 · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00214 ON OCTOBER 04, 2017. 10/04/2017 CORRECTION: IN THE INITIAL MDR, THE INVESTIGATION SUMMARY IS INCORRECT. SIEMENS IS STILL INVESTIGATING. 10/13/2017 ADDITIONAL INFORMATION: THE CUSTOMER TESTED 296 NEGATIVE SAMPLES WITH TOXOPLASMA G LOT 222. THE SPECIFICITY SEEN IS 99.7%. THE RELATIVE SPECIFICITY RESULTS FROM THE THREE STUDIES IN THE ADVIA CENTAUR XP TOXOPLASMA IGG INSTRUCTIONS FOR USE (IFU) (10629904 REVISION AA) RANGE IS FROM 99.3% - 99.8%. THE RECENT SAMPLE ((B)(6) 2017) FOR THE PATIENT WAS TESTED WITH NABT (NON-SPECIFIC ANTIBODY BLOCKING TUBE) AND HBT (HETEROPHILIC BLOCKING TUBE) TUBES AT THE CUSTOMER SITE. RESULTS: INITIAL RESULT: 20 IU/ML. AFTER TREATMENT : NABT RESULT: 20.2 IU/ML, HBT RESULT : 22.4 IU/ML. SIEMENS HEALTHCARE DIAGNOSTICS IS AWAITING FURTHER INFORMATION. MDR 1219913-2017-00211 SUPPLEMENTAL REPORT 1, 1219913-2017-00212 SUPPLEMENTAL REPORT 1 AND 1219913-2017-00213 SUPPLEMENTAL REPORT 1 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TOXOPLASMA G (TOXO G) RESULTS IS UNKNOWN. THERE IS NO SAMPLE AVAILABLE TO BE TREATED WITH A HETEROPHILIC BLOCKING TUBE (HBT). THE POSITIVE RESULTS WITH THE ADVIA CENTAUR XP TOXOPLASMA IGG ASSAY MAY BE DUE TO THE PRESENCE OF HETEROPHILIC ANTIBODIES IN THE PATIENT SAMPLE. IMMUNOASSAYS ARE SUBJECT TO A NUMBER OF INTERFERENCES INCLUDING THOSE CAUSED BY ENDOGENOUS ANTIBODIES. INTERFERENCE CAN OCCUR BECAUSE OF HETEROPHILE ANTIBODIES, ANTI-ANIMAL ANTIBODIES AND AUTO ANTIBODIES. PATIENTS EXPOSED TO ANIMALS OR ANIMAL SERUM PRODUCTS CAN BE PRONE TO THIS INTERFERENCE AND ANOMALOUS VALUES MAY BE OBSERVED. THE INTERFERING ANTIBODIES CAN GIVE RISE TO A FALSELY HIGH OR LESS COMMONLY A FALSELY LOW RESULT. PLEASE NOTE THE INTERFERENT MAY NOT NECESSARILY BE DUE TO AN INTERFERING ANTIBODY BUT MAY BE DUE TO OTHER EXOGENOUS INTERFERENCES SUCH AS DRUGS, NUTRITIONAL SUPPLEMENTS AND/OR HERBAL MEDICINE IN THE BLOOD. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. 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 1219913-2017-00211, 1219913-2017-00212 AND 1219913-2017-00213 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00214 ON OCTOBER 04, 2017. SIEMENS FILED THE MDR 1219913-2017-00214 SUPPLEMENTAL REPORT 1 ON OCTOBER 30, 2017. 11/02/2017 CORRECTION: IN THE MDR 1219913-2017-00214 SUPPLEMENTAL REPORT 1, THE SPECIFICITY INFORMATION FOR THE CUSTOMER WAS INCORRECT. THE CUSTOMER TESTED 425 NEGATIVE SAMPLES WITH TOXOPLASMA G LOT 222 AND THE CORRECT SPECIFICITY IS 99.5%. THE CUSTOMER'S CALCULATED SPECIFICITY FOR LOT 222 IS STILL WITHIN THE IFU RANGE OF 99.3% - 99.8%. 11/09/2017 ADDITIONAL INFORMATION: THE CUSTOMER INFORMED SIEMENS THAT THE PATIENT SAMPLE IS NOT AVAILABLE FOR FURTHER TESTING AND INVESTIGATION. THE CUSTOMER HAD MULTIPLE SAMPLES FROM A PATIENT THAT WERE REACTIVE WITH THE ADVIA CENTAUR XP TOXOPLASMA IGG ASSAY LOTS 220, 221 AND 222 BUT NEGATIVE WITH AN ALTERNATE METHOD TOXOPLASMA IGG ASSAY. SINCE THE SAMPLES RECOVERED REACTIVE WITH MULTIPLE LOTS THIS IS NOT A LOT SPECIFIC ISSUE. SINCE THE SAMPLE RECOVERED REACTIVE WITH MULTIPLE AND DIFFERENT DRAWS SINCE (B)(6) 2017, THIS IS NOT A SYSTEM SPECIFIC ISSUE. NO OTHER PATIENT SAMPLES HAVE BEEN AFFECTED. THE CUSTOMER TESTED THE SAMPLE WITH HETEROPHILIC BLOCKING TUBE (HBT) AND A NON-SPECIFIC ANTIBODY BLOCKING TUBE (NABT) TUBES, BUT THERE WAS NO SIGNIFICANT CHANGE IN DOSE. PLEASE NOTE THE INTERFERENT MAY NOT NECESSARILY BE DUE TO AN INTERFERING ANTIBODY BUT MAY BE DUE TO OTHER EXOGENOUS INTERFERENCES SUCH AS DRUGS, NUTRITIONAL SUPPLEMENTS AND/OR HERBAL MEDICINE IN THE BLOOD. THE CAUSE OF THE ELEVATED RESULTS IS UNKNOWN BUT THIS APPEARS TO BE A SAMPLE SPECIFIC ISSUE. THE CUSTOMER'S CALCULATED SPECIFICITY FOR LOT 222 IS STILL WITHIN THE IFU RANGE OF 99.3% - 99.8%. BASED ON THE AVAILABLE INFORMATION, THE ADVIA CENTAUR XP TOXOPLASMA IGG ASSAY IS PERFORMING AS INTENDED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 1219913-2017-00211 SUPPLEMENTAL REPORT 2, 1219913-2017-00212 SUPPLEMENTAL REPORT 2 AND 1219913-2017-00213 SUPPLEMENTAL REPORT 2 WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE POSITIVE RESULT WAS FOUND TO BE DISCORDANT WITH THE NEGATIVE RESULT FROM AN ALTERNATE METHOD. THE PATIENT IS PREGNANT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. 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
    694237 ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 56941222 00630414208459

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR