BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HAV TOTAL (AHAVT) ASSAY

    MDR report key: 6313976 · Received February 9, 2017

    Report

    Report Number
    1219913-2017-00015
    Event Type
    Malfunction
    Date Received
    February 9, 2017
    Date of Event
    August 1, 2016
    Report Date
    March 7, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOL
    PMA / PMN Number
    P040017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED MDR 1219913-2017-00015 ON FEBRUARY 9, 2017 REPORTING A NUMBER OF (B)(6) SAMPLES WITH THE ADVIA CENTAUR XP (B)(6) ASSAY THAT DID NOT AGREE WITH AN ALTERNATE METHOD. MDR 1219913-2017-00015 SUPPLEMENTAL 1, WAS FILED ON MARCH 7, 2017 WITH ADDITIONAL INFORMATION REGARDING THE INVESTIGATION. FEBRUARY 14, 2018 - ADDITIONAL INFORMATION: SIEMENS' INVESTIGATION SHOWED THAT ALL SPECIFICATIONS ARE MET; HOWEVER A TWO-POINT CALIBRATION BIAS TO THE INTERNAL MASTER CURVE AND A HIGHER BIAS TO WHO MATERIAL THAN WHAT HAS BEEN HISTORICALLY OBSERVED WAS SEEN WITH REAGENT LOT 104077 AND THE SISTER LOT 073182 WHICH EXPIRED JUNE 30, 2017. THESE BIASES COULD MANIFEST AS AN INCREASE IN THE NUMBER OF POSITIVE SAMPLE RESULTS. ADDITIONALLY, SIEMENS REVIEWED SIEMENS REAL TIME SOLUTIONS (SRS) DATA. THIS DATA SHOWS A HIGHER PERCENTAGE OF PATIENTS ABOVE THE ASSAY CUTOFF WITH REAGENT LOT 104077 (073182) THAN SEEN WITH OTHER REAGENT LOTS. THE BIAS AND THE INCREASE IN THE NUMBER OF (B)(6) SAMPLE RESULTS ARE LIMITED TO THIS REAGENT LOT(S). SIEMENS DETERMINED THAT THE INCREASE IN THE NUMBER OF (B)(6) SAMPLE RESULTS WAS NOT DUE TO A SHIPPING OR HANDLING ISSUE WITH THE REAGENTS AS REAGENTS RETURNED TO SIEMENS PERFORMED SIMILARLY TO SIEMENS' RETAINS. ROOT CAUSE WAS NOT ABLE TO BE DETERMINED PRIOR TO LOT EXPIRATION AND THE ISSUE DOES NOT APPEAR TO BE A SYSTEMIC (B)(6) TOTAL PROBLEM. ALTHOUGH ROOT CAUSE HAS NOT BEEN IDENTIFIED AND THE PRODUCT MET ALL SPECIFICATIONS, SIEMENS IS EVALUATING OPPORTUNITIES FOR PROCESS IMPROVEMENTS TO REDUCE THE POTENTIAL THAT FUTURE LOTS WOULD EXHIBIT SIMILAR PERFORMANCE.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE (B)(6) PATIENT RESULTS COMPARED TO AN ALTERNATE METHOD IS UNKNOWN. THE CUSTOMER'S QUALITY CONTROL RESULTS WERE ACCEPTABLE AT THE TIME OF THE TESTING. SIEMENS IS INVESTIGATING THIS INCIDENT AND HAS REQUESTED THE PATIENT SAMPLES FOR INVESTIGATION. ADVIA CENTAUR (B)(4) REAGENT LOT 073182; DATE OF MANUFACTURE 06-30-2016; EXPIRATION DATE 06-30-2017; UDI - TO BE PROVIDED.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED MDR 1219913-2017-00015 ON FEBRUARY 9, 2017 REPORTING A NUMBER OF (B)(6) SAMPLES WITH THE ADVIA CENTAUR XP HAV TOTAL (AHAVT) ASSAY THAT DID NOT AGREE WITH AN ALTERNATE METHOD. MARCH 7, 2017 ADDITIONAL INFORMATION: SIEMENS EVALUATED THE STANDARDIZATION OF THE ADVIA CENTAUR XP AHAVT IN COMPARISON TO WHO STANDARDIZATION AND FOUND THAT WHO STANDARDS AND MASTER CURVE STANDARDS ARE CLOSE TO TARGET. THE 2PT CALIBRATION RESULTS ARE BIASED HIGH COMPARED TO THE WHO STANDARDS AND MASTER CURVE STANDARDS. SIEMENS ALSO IDENTIFIED THAT INTERNAL CONTROLS ARE RUNNING OUTSIDE OF INTERNAL RANGES. SIEMENS CONTINUES TO INVESTIGATE THE ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY ARE OBSERVING (B)(6) RESULTS WITH THE ADVIA CENTAUR (B)(4) ASSAY. THE RESULTS DO NOT AGREE WITH AN ALTERNATE METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED BASED ON THE ADVIA CENTAUR XP (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101763 ADVIA CENTAUR XP HAV TOTAL (AHAVT) ASSAY HEPATITIS A VIRUS (ANTI-HAV) ASSAY LOL SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 073180

    Patients

    Seq Age Sex Outcome Treatment
    1