BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY

    MDR report key: 6786236 · Received August 10, 2017

    Report

    Report Number
    1219913-2017-00178
    Event Type
    Malfunction
    Date Received
    August 10, 2017
    Date of Event
    July 17, 2017
    Report Date
    August 28, 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
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00178 ON 08/10/2017 FOR A FALSE HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) PATIENT RESULT. 08/11/17 - ADDITIONAL INFORMATION: THE CUSTOMER WAS PROVIDED MASTER CURVE MATERIAL FOR TROUBLESHOOTING, AND THE RESULTS WERE WITHIN ESTABLISHED RANGES. A CORRELATION STUDY WAS PERFORMED WITH NEW REAGENTS OF THE SAME LOT, AND THE RESULTS ACCEPTABLE (CUSTOMER DATA NOT PROVIDED). THE CUSTOMER HAS DECLINED ANY FURTHER ASSISTANCE. THE CAUSE FOR THE FALSE HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) PATIENT RESULT COMPARED TO A LOWER ADVIA CENTAUR SYSTEM IPTH RESULT FROM A SISTER HOSPITAL IN UNKNOWN. NO CONCLUSION CAN BE DRAWN. CUSTOMER MASTER CURVE MATERIAL RESULTS: LEVEL: MCM1, TARGET: 0, RANGE: < 7.5, RESULT: 1. MCM2, 28.1, 18.3 - 37.9, 29. MCM3, 50.6, 32.9 - 68.3, 53. MCM4, 132.0, 92.4 - 172.0, 135. MCM5, 345.0, 242.0 - 449.0, 353. MCM6, 866.0, 606.0 - 1126.0, 893. MCM7, >1900, > 1900, 2493. 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 TWO 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." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSE HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT IS UNKNOWN. THE CUSTOMER HAS PERFORMED ADDITIONAL STUDIES (STUDY RESULTS NOT PROVIDED) AND IS REPORTING PATIENT RESULTS WITH THE NEW IPTH REAGENT LOT (056368). 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 TWO 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."

    Description of Event or Problem · 1

    A FALSE HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT WAS OBTAINED, AND CONSIDERED DISCORDANT COMPARED TO A LOWER ADVIA CENTAUR SYSTEM IPTH RESULT FROM A SISTER HOSPITAL. THE CUSTOMER INITIALLY OBSERVED A HIGH BIAS FOR LEVEL 3 QUALITY CONTROL (QC) EVEN THOUGH QC WAS WITHIN THE LABORATORY'S ESTABLISHED RANGE. THERE WAS NO QC IMPROVEMENT WITH A NEW IPTH REAGENT LOT (056368), AND THE FALSE HIGH IPTH RESULT WAS OBSERVED WHEN PERFORMING A PATIENT RESULT COMPARISON WITH THE SISTER HOSPITAL. PER THE LABORATORY DIRECTOR, PATIENT RESULTS GREATER THAN 73 PG/ML WILL BE HELD FOR VERIFICATION TESTING. 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
    567533 ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY IPTH IMMUNOASSAY, CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 056366 00630414579153

    Patients

    Seq Age Sex Outcome Treatment
    1