BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY

    MDR report key: 6889853 · Received September 25, 2017

    Report

    Report Number
    1219913-2017-00206
    Event Type
    Malfunction
    Date Received
    September 25, 2017
    Date of Event
    September 1, 2017
    Report Date
    October 4, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    UDI-DI
    00630414579153
    PMA / PMN Number
    K133601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT IPTH RESULTS IS UNKNOWN. THE PATIENT SAMPLES ARE NOT AVAILABLE FOR FURTHER TESTING AND EVALUATION. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES: "RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS. 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."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00206 ON (B)(6) 2017. 09/26/2017 ADDITIONAL INFORMATION: THE CUSTOMER'S REFERENCE RANGE IS 14-72 PG/ML AND THE REFERENCE RANGE FOR REFERENCE LABORATORY IS 14.0-63 PG/ML. THE QUALITY CONTROL AND CALIBRATIONS ARE VALID. THE CUSTOMER HAD RERUN SURVEY SAMPLES USING THE SAME REGENT LOT AND THE RESULTS WERE ALL WITHIN ACCEPTABLE LIMITS. THE CUSTOMER TYPICALLY RUNS EDTA SAMPLES. THE REFERENCE RANGE FOR EDTA AS STATED IN THE IFU IS 13.8 TO 85 PG/ML. THE CUSTOMER INDICATED THEY WOULD REVISE THEIR REFERENCE RANGES TO REFLECT EDTA SAMPLES.THE PATIENT SAMPLES ARE NOT AVAIALBLE FOR FURTHER TESTING AND EVALUATION. THEREFORE, SIEMENS IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE DISCORDANT RESULTS. THE CUSTOMER REPEATED THE CORRELATION USING 10 SAMPLES WITH ANOTHER SITE. THE SLOPE OBSERVED WAS 1.03 BETWEEN THE TWO SITES. THE CORRELATION IS ACCEPTABLE BETWEEN THE TWO SITES. THE CAUSE FOR THE DISCORDANT IPTH RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE EXPECTED VALUES SECTION: "THE REFERENCE RANGE WAS ESTABLISHED ON THE ADVIA CENTAUR SYSTEM. MATCHED EDTA PLASMA AND SERUM SAMPLES WERE OBTAINED FROM 180 APPARENTLY HEALTHY INDIVIDUALS WHOSE CALCIUM LEVELS RANGED FROM 8.0 TO 10.3 MG/DL. THE EXPECTED RESULTS (FROM 95% OF THE VALUES) ARE: FOR PLASMA: 13.8-85.0 PG/ML (1.46-9.01 PMOL/L), FOR SERUM: 12.4-76.8 PG/ML (1.31-8.14 PMOL/L)." 10/04/2017 CORRECTION: (B)(6).

    Description of Event or Problem · 1

    DISCORDANT HIGH ADVIA CENTAUR XP IPTH RESULT WAS OBTAINED FOR SAMPLES FROM SEVERAL PATIENTS DURING A COMPARISON STUDY. THE COMPARISON STUDY WAS BETWEEN REAGENT LOT 368 ON THE ADVIA CENTAUR XP AND AN ALTERNATE METHOD. THE COMPARISON WAS PERFORMED AFTER THE CUSTOMER RECEIVED COMPLAINTS FROM DOCTORS ABOUT SHIFT UP IN RESULTS ON PATIENT SAMPLES. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THESE DISCORDANT IPTH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672597 ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 51223368 00630414579153

    Patients

    Seq Age Sex Outcome Treatment
    1