BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY

    MDR report key: 6755774 · Received July 31, 2017

    Report

    Report Number
    1219913-2017-00173
    Event Type
    Malfunction
    Date Received
    July 31, 2017
    Date of Event
    July 6, 2017
    Report Date
    October 11, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    UDI-DI
    00630414579153
    PMA / PMN Number
    K133601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00173 ON 07/31/2017 FOR A FALSE LOW ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT PATIENT RESULT, MDR 1219913-2017-00173 SUPPLEMENTAL REPORT 1 ON 08/28/2017 FOR ADDITIONAL INFORMATION, AND MDR 1219913-2017-00173 SUPPLEMENTAL REPORT 2 ON 09/20/2017 FOR A CATALOG NUMBER CORRECTION. 09/21/2017 - ADDITIONAL INFORMATION: THE CAUSE FOR THE FALSELY LOW DISCORDANT ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT PATIENT RESULT IS UNKNOWN. THE CUSTOMER'S QUALITY CONTROL (QC), AND IPTH ASSAY CALIBRATION WERE VALID AT THE TIME OF THE INCIDENT. THE PATIENT'S RESULT WHEN REDRAWN, AND REPEATED FIVE DAYS LATER WAS NORMAL. SIEMENS CANNOT RULE OUT PRE-ANALYTICAL FACTORS AS THE POTENTIAL CAUSE OF THE FALSELY LOW DISCORDANT. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: 'RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATION SECTION STATES THE FOLLOWING: "INTERPRETATION OF INTACT PTH VALUES SHOULD ALWAYS TAKE INTO ACCOUNT SERUM CALCIUM RESULTS AND THE INTERRELATIONSHIP BETWEEN THESE 2 ELEMENTS IN VARIOUS DISORDERS INVOLVING PTH AND CALCIUM. IT IS RECOMMENDED THAT THE INTACT PTH RESULTS SHOULD ALWAYS BE INTERPRETED WITH CAUTION AND WITH CONSIDERATION OF THE OVERALL CLINICAL MANIFESTATIONS EVEN WHEN USED IN CONJUNCTION WITH CALCIUM VALUES." MDR 1219913-2017-00166, MDR 1219913-2017-00166 SUPPLEMENTAL REPORT 1, AND MDR 1219913-2017-00166 SUPPLEMENTAL REPORT 2 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00173 ON 07/31/2017 FOR A FALSE LOW ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT PATIENT RESULT AND MDR 1219913-2017-00173 SUPPLEMENTAL REPORT 1 ON 08/28/2017 FOR ADDITIONAL INFORMATION. 09/08/2017 - CORRECTION: THE CATALOG # 10699154 (100 TESTS) INITIALLY STATED WAS INCORRECT. SIEMENS HAS CONFIRMED WITH THE CUSTOMER THAT THE CORRECT CATALOG # IS10699155 (500 TESTS). SIEMENS IS INVESTIGATING. THE INSTRUCTION FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: 'RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATION SECTION STATES THE FOLLOWING: "INTERPRETATION OF INTACT PTH VALUES SHOULD ALWAYS TAKE INTO ACCOUNT SERUM CALCIUM RESULTS AND THE INTERRELATIONSHIP BETWEEN THESE 2 ELEMENTS IN VARIOUS DISORDERS INVOLVING PTH AND CALCIUM. IT IS RECOMMENDED THAT THE INTACT PTH RESULTS SHOULD ALWAYS BE INTERPRETED WITH CAUTION AND WITH CONSIDERATION OF THE OVERALL CLINICAL MANIFESTATIONS EVEN WHEN USED IN CONJUNCTION WITH CALCIUM VALUES." MDR 1219913-2017-00166, AND MDR 1219913-2017-00166 SUPPLEMENTAL REPORT 1 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00173 ON 07/31/2017 FOR A FALSE LOW ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT PATIENT RESULT. (B)(6) 2017 - ADDITIONAL INFORMATION: THE GENDER FOR THIS PATIENT IS MALE. SIEMENS IS INVESTIGATING. THE INSTRUCTION FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: 'RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATION SECTION STATES THE FOLLOWING: "INTERPRETATION OF INTACT PTH VALUES SHOULD ALWAYS TAKE INTO ACCOUNT SERUM CALCIUM RESULTS AND THE INTERRELATIONSHIP BETWEEN THESE 2 ELEMENTS IN VARIOUS DISORDERS INVOLVING PTH AND CALCIUM. IT IS RECOMMENDED THAT THE INTACT PTH RESULTS SHOULD ALWAYS BE INTERPRETED WITH CAUTION AND WITH CONSIDERATION OF THE OVERALL CLINICAL MANIFESTATIONS EVEN WHEN USED IN CONJUNCTION WITH CALCIUM VALUES." MDR 1219913-2017-00166 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSE LOW ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT IS UNKNOWN. SIEMENS IS INVESTIGATING. THE INSTRUCTION FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: 'RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATION SECTION STATES THE FOLLOWING: "INTERPRETATION OF INTACT PTH VALUES SHOULD ALWAYS TAKE INTO ACCOUNT SERUM CALCIUM RESULTS AND THE INTERRELATIONSHIP BETWEEN THESE 2 ELEMENTS IN VARIOUS DISORDERS INVOLVING PTH AND CALCIUM. IT IS RECOMMENDED THAT THE INTACT PTH RESULTS SHOULD ALWAYS BE INTERPRETED WITH CAUTION AND WITH CONSIDERATION OF THE OVERALL CLINICAL MANIFESTATIONS EVEN WHEN USED IN CONJUNCTION WITH CALCIUM VALUES." MDR 1219913-2017-00166 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A FALSE LOW ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT WAS OBSERVED BY THE CUSTOMER ON A PATIENT (BABY), AND CONFIRMED LOW WITH AN ALTERNATE IPTH TEST METHOD. THE LOW IPTH RESULT WAS QUESTIONED BY THE PHYSICIAN, THE PATIENT WAS REDRAWN, AND THE IPTH RESULT WHEN RUN ON ANOTHER ADVIA CENTAUR SYSTEM WAS NORMAL. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP IPTH RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536473 ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY IPTH IMMUNOASSAY, CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 139001 00630414579153

    Patients

    Seq Age Sex Outcome Treatment
    1 27 DA