BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP AFP ASSAY

    MDR report key: 8199490 · Received December 27, 2018

    Report

    Report Number
    1219913-2018-00307
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    December 11, 2018
    Report Date
    January 11, 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
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED MDR 1219913-2018-00307 ON 12/27/2018 FOR A FALSELY ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) PATIENT RESULT. 01/08/2019 - CORRECTION: THE DATE OF EXPIRATION FOR THE YEAR IN D5 WAS A TYPOGRAPHICAL ERROR. EXPIRATION DATE - 5/15/2019. 01/08/2019 - ADDITIONAL INFORMATION: SIEMENS HAS COMPLETED THE INCIDENT INVESTIGATION. THE CUSTOMER'S ASSAY CALIBRATION AND QUALITY CONTROLS (QC) WERE ACCEPTABLE AT THE TIME OF THE INCIDENT. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) CHECKED THE SYSTEM, AND NO ISSUES WERE OBSERVED, HOWEVER THE BASE PUMP AND PINCH VALVE TUBING WERE REPLACED, AND SEALING OF THE WASH PROBE. THE SAMPLE IS NOT AVAILABLE FOR FURTHER TESTING. SIEMENS HAS NOT IDENTIFIED OTHER ASSAY RELATED COMPLAINTS REGARDING ROOT CAUSE INVESTIGATIONS. REAGENT LOT 041199 QUALITY CONTROL KIT RELEASE DATA WAS REVIEWED, AND NO ABNORMAL HIGH RESULTS WERE OBSERVED. THE CAUSE FOR THE FALSELY ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) PATIENT RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSELY ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) PATIENT RESULT IS UNKNOWN. THE CUSTOMER'S ASSAY CALIBRATION AND QUALITY CONTROLS (QC) WERE ACCEPTABLE. A SIEMENS APPLICATION SPECIALIST WAS AT THE CUSTOMER SITE PREVIOUSLY, AND OBSERVED AN OUTLIER WHEN PERFORMING A PRECISION CHECK. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) CHECKED THE SYSTEM, AND NO ISSUES WERE OBSERVED. SIEMENS IS INVESTIGATING THE EVENT. THE INSTRUCTION FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: "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

    A FALSELY ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) RESULT WAS OBSERVED ON A PATIENT SAMPLE. THE CUSTOMER PERFORMED REPEAT AFP TESTING ON THE SAME SAMPLE, AND INSTRUMENT WITHOUT ADDITIONAL SAMPLE CENTRIFUGATION, AND THE RESULTS WERE LOWER. THE ELEVATED AFP RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP AFP RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038526 ADVIA CENTAUR XP AFP ASSAY KIT, TEST, ALPHA-FETOPROTEIN FOR TESTICULAR CANCER; KIT, TEST, ALPHA-FETOPROTEIN LOJ SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 041199 00630414177335

    Patients

    Seq Age Sex Outcome Treatment
    1