BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY

    MDR report key: 6818896 · Received August 24, 2017

    Report

    Report Number
    1219913-2017-00183
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    August 3, 2017
    Report Date
    September 18, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    UDI-DI
    00630414579160
    PMA / PMN Number
    K133601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NOT ENOUGH SAMPLE TO PERFORM SERIAL DILUTION TO RULE OUT HAMMA OR HETEROPHILIC INTERFERENCE. THE REMAINING SAMPLE WAS SENT TO A REFERENECE LABORATORY FOR IPTH DETERMINATION. THE RESULT WAS NOT PROVIDED. 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. HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS. PATIENTS ROUTINELY EXPOSED TO ANIMALS OR TO ANIMAL SERUM PRODUCTS CAN BE PRONE TO THIS INTERFERENCE AND ANOMALOUS VALUES MAY BE OBSERVED. ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00183 ON AUGUST 24, 2017. 08/25/2017 ADDITIONAL INFORMATION: THE PHYSICIAN WAS EXPECTING A NORMAL IPTH RESULT. THE ONLY INFORMATION PROVIDED WAS THAT THE CLINICAL CHEMISTRY TESTS FOR THE PATIENT WERE NORMAL AND NO INTRA-OPERATIVE IPTH WAS EVER ORDERED. THE PATIENT SAMPLE WAS SENT TO A REFERENCE LABORATORY FOR IPTH TESTING AND THE SENDOUT RESULT WAS REPORTED AS THE FINAL RESULT. THE CUSTOMER COULD NOT FIND THE SEND OUT REPORT TO PROVIDE THE TEST METHOD OR RESULT OBTAINED TO SIEMENS. THE PATIENT SAMPLE IS NOT AVAILABLE FOR IN-HOUSE TESTING. THEREFORE, THE CAUSE OF THE DISCORDANT IPTH RESULT CAN NOT BE DETERMINED. SIEMENS CANNOT RULE OUT A POTENTIAL UNIDENTIFIED INTERFERENCE IN THE PATIENT SAMPLE . THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XP IPTH RESULTS WERE OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE HAD A RESULT GREATER THAN 1900. THE SAMPLE WAS DILUTED (1:5) AND THE RESULTS WERE LOW. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THESE DISCORDANT IPTH RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599578 ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 38520368 00630414579160

    Patients

    Seq Age Sex Outcome Treatment
    1