BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM TOXOPLASMA IGG (TOXO G)

    MDR report key: 12206572 · Received July 21, 2021

    Report

    Report Number
    1219913-2021-00384
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 16, 2021
    Report Date
    March 24, 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

    SIEMENS FILED MDR 1219913-2021-00384 INITIAL REPORT ON 21-JUL-2021 FOR A DISCORDANT, FALSE REACTIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULT OBTAINED ON A PATIENT SAMPLE. 23-JUL-2021. ADDITIONAL INFORMATION: THE PATIENT SAMPLES WERE CENTRIFUGED FOR 11 MINUTES AT 2200 G FORCE WITH FIXED ROTATION AND FOLLOWING THE MANUFACTURER'S RECOMMENDATIONS. APPROXIMATELY (B)(6) TOXO G SAMPLES HAVE BEEN PROCESSED BY THE CUSTOMER WITH REAGENT LOT 270. OF THESE, THERE HAVE BEEN (B)(6) NONREACTIVE RESULTS, 812 REACTIVE RESULTS AND 23 INDETERMINATE RESULTS. SIEMENS HAS REQUESTED THE PATIENT SAMPLES FOR INTERNAL TESTING AND CONTINUES TO INVESTIGATE.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED MDR 1219913-2021-00384 INITIAL REPORT ON 21-JUL-2021 AND MDR 12219913-2021-00384 SUPPLEMENTAL 1 ON 19-AUG-2021. 24-JAN-2022- ADDITIONAL INFORMATION AN INTERNAL STUDY WAS COMPLETED ASSESSING 50 PATIENT SAMPLES FROM FRENCH ACQUISITION (BIOMNIS) AND 50 FROM SIEMENS, 100 PATIENT SAMPLES TOTAL. THE STUDY SHOWED CONCORDANT NONREACTIVE, NONREACTIVE/EQUIVOCAL, REACTIVE/EQUIVOCAL, REACTIVE RESULTS ACROSS ATELLICA IM AND ADVIA CENTAUR XP REAGENT LOTS 268, 269, 270, 271, 272, AND 273. SIEMENS RETRIEVED SIEMENS REMOTE SERVICE (SRS) DATA FOR ATELLICA IM TXOG LOTS 268, 270 AND 272. THE THREE LOTS HAVE SIMILAR INTERPRETATION RECOVERY. NEGATIVE: 268; 5.2%, 270 ;86.1%, 272; 86.7%. EQUIVOCAL: 0.9%, 0.9%, 0.9%. POSITIVE: 14.0% , 13.0%, 12.4%. SRS DATA CONFIRMS THAT REAGENT LOT 270 IS PERFORMING SIMILARLY TO OTHER REAGENT LOTS. SIEMENS CONTINUES TO INVESTIGATE.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED MDR 1219913-2021-00384 INITIAL REPORT ON 21-JUL-2021, MDR 12219913-2021-00384 SUPPLEMENTAL 1 ON 19-AUG-2021 AND MDR 12219913-2021-00384 SUPPLEMENTAL 2 ON 02-FEB-2022. 23-MAR-2022- ADDITIONAL INFORMATION. AN OUTSIDE THE UNITED STATES CUSTOMER OBSERVED A FALSE REACTIVE RESULT ON A PREGNANT PATIENT ON ATELLICA IM (AIM) 1600 TOXOPLASMA IGG (TXOG) WITH LOT 270 COMPARED TO TWO ALTERNATE METHODS. THE SAMPLE WAS REPEATED ON THEIR ALTERNATE ATELLICA IM SYSTEM WITH TXOG LOT 270 AND STILL RECOVERED REACTIVE. HISTORIC RESULTS (3 DIFFERENT DRAWS) OF THIS PATIENT WERE NON-REACTIVE FOR TXOG WHEN TESTED ON THE SAME ATELLICA IM SYSTEM WITH LOT 268 AND AN ALTERNATE METHOD. THE CUSTOMER REPEATED THE OLDER SAMPLES ON ATELLICA IM WITH TXOG LOT 270 AND ALL WERE REACTIVE. CALIBRATIONS WERE VALID AND QUALITY CONTROL (QC) RECOVERY WAS WITHIN INSERT RANGES. SIEMENS PERFORMED A STUDY WITH FIFTY (50) NORMAL PATIENT SAMPLES FROM MANUFACTURING AND FIFTY (50) PATIENT SAMPLES FROM FRANCE. THE 100 SAMPLES WERE TESTED IN REPLICATES OF 3 (N=3) WITH AIM LOTS 268, 270 AND 272. 92 SAMPLES RECOVERED THE SAME INTERPRETATIONS WITH ALL 3 LOTS AND 8 PATIENTS RECOVERED NEGATIVE/EQUIVOCAL COMPARING THE 3 TXOG LOTS. SIEMENS RETRIEVED PATIENT FIELD DATA AND LOT 270 RECOVERED SIMILARLY WITH OTHER LOTS. THE PATIENT SAMPLES WERE RETURNED, AND INTERNAL TESTING REPLICATED THE CUSTOMER'S OBSERVATIONS OF FALSE ELEVATED DOSE VALUE FOR REAGENT LOT 270, COMPARED TO REAGENT LOTS 268 AND 272. HBT TREATMENT OF RETURNED SAMPLES RESULTED IN ELEVATED DOSE VALUES ACROSS ALL REAGENT LOTS, SUGGESTING A SAMPLE SPECIFIC INTERFERENT CAUSING THE DISCORDANCE SEEN FOR REAGENT LOT 270. THERE IS INSUFFICIENT SAMPLE VOLUMES AND TXOG LOT 270 EXPIRED ON JANUARY 12, 2022 SO NO FURTHER TESTING AND INVESTIGATION CAN TAKE PLACE. THE CALCULATED SPECIFICITY FOR THIS ACCOUNT WITH TXOG LOT 270 IS 11950/11951= 0.999 X100= 99.99%. THE INITIAL RELATIVE SPECIFICITY RESULTS FROM THE 3 STUDIES IN THE ATELLICA IM TXOG INSTRUCTIONS FOR USE (IFU) 10995430_EN REV. 02, 2019-08 RANGE FROM 97.7%- 99.8%. BASED ON THE AVAILABLE INFORMATION ATELLICA IM TOXOPLASMA IGG LOT 270 IS PERFORMING AS INTENDED AND A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. CUSTOMER IS OPERATIONAL AND NO FURTHER ACTION REQUIRED. IN SECTION H6, TYPE OF INVESTIGATION, INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED BASED ON ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT A DISCORDANT, FALSE REACTIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) PATIENT RESULT. ASSAY CALIBRATION AND QUALITY CONTROL (QC) WERE DEEMED TO BE ACCEPTABLE. THE CUSTOMER HAS TESTED AND OBSERVED APPROXIMATELY 5500 TOXO G NEGATIVE RESULTS WITH REAGENT LOT 270 SINCE MAY 21, 2021. SIEMENS IS INVESTIGATING. THE CUSTOMER PERFORMED REPEAT ATELLICA IM TOXO G TESTING OF SAMPLES ORIGINALLY TESTED FROM THE SAME PATIENT ON THE SAME ATELLICA IM SYSTEM AND ALTERNATE ATELLICA IM SYSTEM FOR TROUBLESHOOTING PURPOSES. (B)(6). THE INSTRUCTION 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." THE INSTRUCTION FOR USE (IFU) STATES IN THE LIMITATIONS SECTION: "SPECIMENS COLLECTED IN THE EARLY STAGES OF INFECTION MAY HAVE IGG LEVELS THAT ARE CLASSIFIED AS NEGATIVE". "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."

    Description of Event or Problem · 1

    A FALSE REACTIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULT WAS OBSERVED BY THE CUSTOMER ON A PATIENT SAMPLE. THE REACTIVE TOXO G RESULT WAS CONSIDERED DISCORDANT COMPARED TO PREVIOUS NONREACTIVE TOXO G TEST HISTORY RESULTS AND ALTERNATE TEST METHOD RESULTS. THE REACTIVE ATELLICA IM TOXO G RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER WHEN TROUBLESHOOTING THE OBSERVED ISSUE, PERFORMED REPEAT TESTING OF SAMPLES ORIGINALLY TESTED FROM THE SAME PATIENT ON THE SAME ATELLICA IM SYSTEM AND ALTERNATE ATELLICA IM SYSTEM, ALL RESULTING REACTIVE. THE CUSTOMER SENT THE PATIENT SAMPLE AND A PREVIOUSLY TESTED SAMPLE (MAY) TO A SECOND ALTERNATE FACILITY AND ALTERNATE TEST METHOD, RESULTING NONREACTIVE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE REACTIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104450 ATELLICA IM TOXOPLASMA IGG (TOXO G) TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 270 00630414600123

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female