BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    MDR report key: 8125360 · Received December 3, 2018

    Report

    Report Number
    1219913-2018-00293
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 6, 2018
    Report Date
    January 3, 2019
    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 1219913-2018-00293 ON DECEMBER 03, 2018. 12/08/2018 ADDITIONAL INFORMATION: THE PATIENT SAMPLE WAS RECEIVED FOR FURTHER TESTING AND INVESTIGATION. THE CUSTOMER RETURNED PATIENT SAMPLE WAS TESTED WITH ADVIA CENTAUR XP TOXO G REAGENT LOTS 061234 AND 061238 AND WITH IMMULITE TXP REAGENT LOT 442. THE SAMPLE WAS RUN NEAT AT N=3 ON BOTH INSTRUMENTS, AND WITH ALL REAGENT LOTS. ALL REPLICATES OF THE SAMPLE RECOVERED REACTIVE ON THE ADVIA CENTAUR XP FOR BOTH TOXO G LOTS 061234 AND 061238 AND NON-REACTIVE ON IMMULITE 2000 WITH TXP LOT 442. THE SAMPLE WAS THEN TREATED WITH HETEROPHILIC BLOCKING TUBE (HBT) AND NON-SPECIFIC ANTIBODY BLOCKING TUBE (NABT) AND WAS RUN AT N=3 ON BOTH ADVIA CENTAUR XP TOXO G) REAGENT LOTS. ALL REPLICATE RESULTS POST HBT AND NABT TREATMENT WERE STILL REACTIVE ON THE ADVIA CENTAUR XP FOR BOTH TOXO G REAGENT LOTS 061234 AND 061238. RESULTS: ADVIA CENTUAR XP (S/N IRL (B)(4)), TOXO G (IU/ML): LOT # 061234 LOT # 061238 PATIENT NEAT: REP #1, 130.3, 125.5. REP #2, 130.0, 126.2. REP #3, 131.2, 126.4 . PATIENT HBT : REP #1, 141.7, 124.5. REP #2, 136.9, 127.8. REP #3, 131.9, 129.5. IMMULITE 2000 XPI (S/N (B)(4)), TXP (IU/ML): LOT #442 PATIENT NEAT: REP #1, <5.00. REP #2, <5.00. REP #3, <5.00. ADVIA CENTUAR XP (S/N IRL (B)(4)), TOXO G ( IU/ML): LOT # 061234 LOT # 061238 PATIENT NABT: REP #1, 139.7 , 123.1. REP #2, 134.5 , 130.3. REP #3, 143.0, 128.9. THE SUMMARY RESULTS REPLICATE THE CUSTOMER'S OBSERVATIONS WITH THIS PATIENT SAMPLE AND INDICATE THAT THIS IS NEITHER AN ADVIA CENTAUR TOXO G LOT SPECIFIC ISSUE NOR A SITE/SYSTEM SPECIFIC ISSUE. THE INTERNAL STUDY RESULTS ARE INDICATIVE OF A SAMPLE SPECIFIC ISSUE AND DO NOT CONFIRM A SIEMENS PRODUCT NON-CONFORMANCE. PER ADVIA CENTAUR XP TOXOPLASMA G INSTRUCTIONS FOR USE (IFU) (10629904 REVISION AA, 2016-04) "THE CALCULATED VALUES FOR TOXOPLASMA IGG IN A GIVEN SPECIMEN, AS DETERMINED BY ASSAYS FROM DIFFERENT MANUFACTURERS, CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY. THE RESULTS REPORTED BY THE LABORATORY TO THE PHYSICIAN MUST INCLUDE THE IDENTITY OF THE TOXOPLASMA IGG ASSAY USED". CUSTOMER HAS NOT REPORTED ANY NEW INCIDENTS OF FALSE REACTIVE TOXO G RESULTS AND THIS ISSUE IS CONSIDERED TO BE AN ISOLATED AND SAMPLE SPECIFIC INCIDENT. BASED ON THE AVAILABLE INFORMATION, THE ADVIA CENTAUR XP TOXOPLASMA G LOT 061234 IS PERFORMING AS INTENDED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 1219913-2018-00292 SUPPLEMENTAL REPORT 1 AND MDR 1219913-2018-00294 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. SIEMENS HEALTHCARE DIAGNOSTICS HAS REQUESTED THE PATIENT SAMPLE FOR FURTHER TESTING AND INVESTIGATION. 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 1219913-2018-00292 AND MDR 1219913-2018-00294 WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) RESULTS WERE OBTAINED ON THREE DIFFERENT DRAWS FROM THE SAME PATIENT. THE POSITIVE RESULTS WERE FOUND TO BE DISCORDANT WITH THE HISTORICAL NEGATIVE RESULTS FROM TWO ALTERNATE METHODS. THE TOXO M RESULTS WERE NEGATIVE ON THE ADVIA CENTAUR XP PLATFORM AND THE OTHER METHODS. PREGNANT WOMAN. 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
    963673 ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 24999234 00630414208459

    Patients

    Seq Age Sex Outcome Treatment
    1