BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP AFP

    MDR report key: 8666591 · Received June 4, 2019

    Report

    Report Number
    1219913-2019-00096
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 2, 2019
    Report Date
    August 16, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOJ
    UDI-DI
    00630414177335
    PMA / PMN Number
    K020806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR (B)(6) ON (B)(6)2019 AND THE SUPPLEMENTAL REPORT ON(B)(6)2019. AUGUST 2, 2019 - ADDITIONAL INFORMATION: AS PREVIOUSLY REPORTED IN MDR (B)(6) SUPPLEMENTAL 1, SIEMENS' HAS COMPLETED THE INVESTIGATION INTO AN ALLEGED ELEVATED AFP VALUE THAT WAS REPRODUCIBLY OBTAINED ON THE ADVIA CENTAUR XP. SIEMENS OBTAINED THE SAMPLE AND RAN THE SAMPLE WITH TWO SEPARATE LOTS OF AFP INCLUDING LOT 203 AND LOT 214. THE PATIENT RESULTED 101 NG/ML ON LOT 203 AND 101 ON LOT 214. THE SAMPLE WAS THEN TREATED WITH A NABT TUBE BUT THE SIGNAL WAS NOT REDUCED THEREFORE THE PRESENCE OF NON SPECIFIC ANTIBODIES COULD NOT BE CONFIRMED. AS THE PATIENT IS ON THE CONTRACEPTIVE MIRENA IT IS LESS LIKELY THEY ARE PREGNANT THEREFORE THE PATIENT IS MOST LIKELY BEING TESTED AS A POTENTIAL ONCOLOGY PATIENT. SIEMENS' PROVIDED THIS INFORMATION TO THE CUSTOMER AND REQUESTED ADDITIONAL INFORMATION REGARDING THE MEDICAL STATUS OF THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. AT THIS TIME THERE HAS BEEN NO PRODUCT NON CONFORMANCE IDENTIFIED AND NO DATA SUPPLIED INDICATING PERFORMANCE ISSUES OUTSIDE THIS PATIENT RESULT. NO FURTHER ACTION IS REQUIRED. MDR 1219913-2019-00109 AND 1219913-2019-00109 SUPPLEMENTAL REPORT 1 AND 1219913-2019-00109 SUPPLEMENTAL REPORT 2 WERE ALSO FILED FOR THIS EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2019-00096 ON JUNE 4, 2019. 06/28/2019 ADDITIONAL INFORMATION: SIEMENS HAS COMPLETED THE TESTING OF THE RETURNED SAMPLE ON TWO SEPARATE LOTS OF AFP (LOT 203 AND LOT 214). ADVIA CENTAUR XP S/N (B)(6) AFP RESULTS (NG/ML): PATIENT SAMPLE NEAT WITH LOT 041203: 101.6 AND 101.2; PATIENT SAMPLE NEAT WITH LOT 041214: 101.3 AND 101.2; PATIENT SAMPLE NABT WITH LOT 041203: 102.8 AND 105.7; PATIENT SAMPLE NABT WITH LOT 041214: 106.0 AND 101.7. THE PATIENT RESULTED 101 NG/ML ON LOT 203 AND 101 ON LOT 214. THE SAMPLE WAS THEN TREATED WITH A NABT TUBE BUT THE SIGNAL WAS NOT REDUCED, THEREFORE WE COULD NOT CONFIRM THE PRESENCE OF NON-SPECIFIC ANTIBODIES. AS THE PATIENT IS ON THE CONTRACEPTIVE MIRENA, IT IS LESS LIKELY THEY ARE PREGNANT. THEREFORE, THE PATIENT IS MOST LIKELY BEING TESTED AS A POTENTIAL ONCOLOGY PATIENT. SIEMENS HEALTHCARE DIAGNOSTICS IS AWAITING FURTHER INFORMATION FROM THE CUSTOMER. MDR 1219913-2019-00109 SUPPLEMENTAL REPORT 1 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT AFP RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. SIEMENS HAS REQUESTED THE SAMPLE FOR TESTING. THE WARNING SECTION OF THE INSTRUCTIONS FOR USE STATES: "WARNING THE CONCENTRATION OF AFP 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 AFP ASSAY USED. VALUES OBTAINED WITH DIFFERENT AFP ASSAY METHODS CANNOT BE USED INTERCHANGEABLY. BEFORE CHANGING ASSAY METHODS, THE LABORATORY MUST DO THE FOLLOWING: -FOR PRENATAL TESTING, THE LABORATORY MUST ESTABLISH A RANGE OF NORMAL VALUES FOR THE NEW ASSAY BASED ON NORMAL SERUM AND AMNIOTIC FLUID FROM PREGNANT WOMEN WITH A CONFIRMED GESTATIONAL AGE. -FOR CANCER MANAGEMENT, THE LABORATORY MUST PERFORM ADDITIONAL TESTING TO CONFIRM BASELINE VALUES FOR PATIENTS BEING SERIALLY MONITORED. UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE TO SALE AND DISTRIBUTION BY OR ON THE ORDER OF A PHYSICIAN, OR TO A CLINICAL LABORATORY; AND USE IS RESTRICTED TO, BY, OR ON THE ORDER OF A PHYSICIAN. USE AFP RESULTS ONLY AS PART OF THE OVERALL CLINICAL EVALUATION OF A PATIENT. DO NOT USE AFP RESULTS AS THE ONLY CRITERION FOR DIAGNOSIS." THE INTERPRETATION OF RESULTS SECTION OF THE INSTRUCTIONS FOR USE STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." MDR 1219913-2019-00096 IS FILED FOR ADVIA CENTAUR XP AFP INITIAL RESULT OF 101.7 NG/ML MDR 1219913-2019-00109 IS FILED FOR ADVIA CENTAUR XP AFP INITIAL RESULT OF 103.6 NG/ML

    Description of Event or Problem · 1

    CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) RESULTS COMPARED TO TWO ALTERNATE METHODS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP AFP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460602 ADVIA CENTAUR XP AFP AFP IMMUNOASSAY LOJ SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 73002203 00630414177335

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR