BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP VB12 ASSAY

    MDR report key: 7508928 · Received May 11, 2018

    Report

    Report Number
    1219913-2018-00150
    Event Type
    Malfunction
    Date Received
    May 11, 2018
    Date of Event
    April 18, 2018
    Report Date
    July 17, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CDD
    UDI-DI
    00630414177168
    PMA / PMN Number
    K993571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR ON MAY 11, 2018. 06/06/2018 CORRECTION: THE CUSTOMER PROVIDED THE REPORTING UNITS AS PG/ML. THREE OTHER PATIENT SAMPLES WERE CONSIDERED DISCORDANT WHEN TESTED ON THE ADVIA CENTAUR XP VB12 (VITAMIN B12) DURING TROUBLESHOOTING. THE RESULTS FOR THE PATIENTS SAMPLES IN PG/ML: SAMPLE NO XP1 XP1 1281288; 208; 252. 1275520; 162; 283. SAMPLE NO XP1 XP2 1317020; 157; 310. XP1 AND XP2 ARE ADVIA CENTAUR XP SYSTEMS 1 AND 2. 06/06/2018 ADDITIONAL INFORMATION: A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSPECTION. THE FSE PERFROMED A TOTAL SERVICE CALL AND NO ISSUES WERE IDENTIFIED. SECTION E4. INITIAL REPORTER ALSO SENT REPORT TO FDA? NO THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE VB12 DISCORDANT RESULTS. SIEMENS HEALTHCARE DIAGNOSTICS CONTINUES TO INVESTIGATE. MDR 1219913-2018-00182 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2018-00150 ON (B)(6)2018.. SIEMENS FILED THE MDR 1219913-2018-00150 SUPPLEMENTAL REPORT 1 ON (B)(6) 2018.. (B)(6)2018 ADDITIONAL INFORMATION: THE RATE OF DISCREPANT RESULTS IS CONSISTENT WITH THE REPRESENTATIVE PRECISION DATA IN THE ADVIA CENTAUR VB12 INSTRUCTIONS FOR USE (IFU). THE CUSTOMER OBSERVED INCIDENT RATE OF DISCREPANT SAMPLES UP TO 15 DISCREPANT RESULTS A DAY OUT OF AN AVERAGE RUN OF 400 VB12 SAMPLES IS 3.8%. THE MAJORITY OF SAMPLES IN QUESTION ARE AT THE VERY LOW END OF NORMAL, AND AT THE HIGH END OF DEFICIENT. THERE IS AN OVERLAP IN THE LOW END OF NORMAL RANGE AND THE HIGH END OF THE DEFICIENT RANGE IN THE IFU WITH VALUES BETWEEN 211 - 246 PG/ML. BASED ON THE REGION'S OBSERVATION AND ANALYSIS, THE DATA SHOWS THAT THE ASSAY IS PERFORMING AS EXPECTED AND THIS IS NORMAL EXPECTED IMPRECISION AT THIS CONCENTRATION WITH A MEAN OF 216 PG/ML . REPLICATES OF SAMPLES IN AND AROUND A CUTOFF WILL FORM A NORMAL DISTRIBUTION AROUND THE MEAN, AND SOME RESULTS TO FALL EITHER SIDE OF THE CUTOFF. FOR EXAMPLE, THE MAS QC WITH A MEAN OF 216.2 WILL RESULT <211 PG/ML 30% OF THE TIME USING THE %CV'S, AND 35% OF THE TIME USING IFU DATA. THE ASSAY IS PERFORMING AS INTENDED BASED ON SIEMENS INTERNAL DATA. THE CUSTOMER IS ABLE TO USE ASSAY FOR PATIENT TESTING, AND IS SATISFIED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 1219913-2018-00182 SUPPLEMENTAL REPORT 1 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT VB12 RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE IFU STATES IN THE INTERPRETATION OF RESULTS SECTION: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS."

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XP VB12 (VITAMIN B12) RESULTS WERE OBTAINED ON A PATIENT SAMPLE DURING TROUBLESHOOTING. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE VB12 DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351938 ADVIA CENTAUR XP VB12 ASSAY VB12 IMMUNOASSAY CDD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 241 00630414177168

    Patients

    Seq Age Sex Outcome Treatment
    1