BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY

    MDR report key: 6554034 · Received May 9, 2017

    Report

    Report Number
    1219913-2017-00124
    Event Type
    Malfunction
    Date Received
    May 9, 2017
    Date of Event
    April 18, 2017
    Report Date
    July 12, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    PMA / PMN Number
    K133601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT IPTH RESULT IS UNKNOWN. THE CUSTOMER IS QUESTIONING IF THE MEDICATIONS FENTANYL, PROPOFOL, AND ROCURONIUM BEING TAKEN AT THE TIME MIGHT HAVE INTEREFERED WITH THE IPTH RESULTS. 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 1219913-2017-00124 ON MAY 9, 2017. ON 06/22/2017 ADDITIONAL INFORMATION: THE CUSTOMER WAS INQUIRING IF SPECIFIC DRUGS, FENTANYL, POFOL, AND ROKURONYUM MAY HAVE IMPACTED TESTING AND CAUSED THE RESULT OF ZERO. THERE HAS BEEN NO RESPONSE AFTER MULTIPLE ATTEMPTS TO OBTAIN THE REQUESTED INFORMATION FROM THE CUSTOMER FOR INVESTIGATION. THE CAUSE FOR THE DISCORDANT IPTH RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED ZERO RESULT ON THE ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY AFTER THYROID SURGERY. A COUPLE OF DAYS LATER, THE TESTING WAS REPEATED ON THE PATIENT SAMPLE AND THE RESULT WAS NORMAL. THE REPEAT RESULT WAS CONSIDERED CORRECT AS IT MATCHED THE CLINICAL PICTURE. THE CUSTOMER STATES SEVERAL PATIENTS WERE AFFECTED. HOWEVER, ACTUAL DATA WAS NOT PROVIDED. IT IS UNKNOWN IF PATIENT TREATMENT WAS 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
    334699 ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 26951362

    Patients

    Seq Age Sex Outcome Treatment
    1