BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP INTACT PARATHYROID HORMONE (IPTH) ASSAY

    MDR report key: 6720604 · Received July 18, 2017

    Report

    Report Number
    1219913-2017-00152
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    June 23, 2017
    Report Date
    August 22, 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
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS SUBMITTED MDR 1219913-2017-00152 ON JULY 18, 2017 REPORTING A LOWER THAN EXPECTED ADVIA CENTAUR CP INTACT PARATHYROID HORMONE (IPTH) RESULT. THAT WAS HIGHER UPON REPEAT TESTING. AUGUST 15, 2017 - ADDITIONAL INFORMATION: AFTER THE SECOND FIELD SERVICE VISIT, NO ADDITIONAL DISCORDANT RESULTS HAVE BEEN OBSERVED. THE DISCORDANT RESULT COULD HAVE BEEN CAUSED BY RINSE BLOCK FAILURE. SINCE THE DISCORDANT RESULT COULD NOT BE REPRODUCED AT THE TIME OF THE TROUBLESHOOTING THIS IS CONSIDERED AN ISOLATED EVENT THAT CANNOT BE CONFIRMED. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT IPTH RESULT IS UNKNOWN. SIEMENS SERVICE WENT ON SITE AND CLEANED THE LUMINOMETER AND VERIFIED REAGENT PROBE ALIGNMENTS. THEY ALSO PERFORMED QC WITH ALL RESULTS IN RANGE. THE SYSTEM WAS RETURNED TO OPERATION. AT A FOLLOW UP VISIT, A TOTAL SERVICE CALL WAS PERFORMED. AN ISSUE WAS FOUND WITH THE RINSE BLOCKS AND THEY WERE REPLACED. SERVICE PERFORMED QC WITH ALL RESULTS IN RANGE. SERVICE ALSO PERFORMED A PRECISION RUN OF 5 REPLICATES WITH ALL EXPECTED RESULTS. THE SYSTEM WAS RETURNED TO OPERATION. NO CONCLUSIONS CAN BE DRAWN. 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." THE INTENDED USE SECTION OF THE INSTRUCTIONS FOR USE STATES: "FOR IN VITRO DIAGNOSTIC USE IN THE QUANTITATIVE DETERMINATION OF INTACT PARATHYROID HORMONE (IPTH) IN EDTA PLASMA OR SERUM USING THE ADVIA CENTAUR CP SYSTEM. THIS ASSAY IS INTENDED TO BE USED TO AID IN THE DIFFERENTIAL DIAGNOSIS OF HYPERPARATHYROIDISM AND HYPOTHYROIDISM."

    Description of Event or Problem · 1

    CUSTOMER OBSERVED A LOWER THAN EXPECTED ADVIA CENTAUR CP INTACT PARATHYROID HORMONE (IPTH) RESULT. UPON REPEAT TESTING, THE RESULT WAS HIGHER. THIS WAS AN INTRAOPERATIVE IPTH TEST RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR CP IPTH RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504404 ADVIA CENTAUR CP INTACT PARATHYROID HORMONE (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 22367367 00630414579153

    Patients

    Seq Age Sex Outcome Treatment
    1