BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

    MDR report key: 5466404 · Received February 29, 2016

    Report

    Report Number
    1219913-2016-00043
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Date of Event
    January 2, 2016
    Report Date
    November 14, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    PMA / PMN Number
    K121981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE QUALITY CONTROL (QC) OUT OF RANGE IS UNKNOWN. THE CUSTOMER COMPARED THEIR IPTH QC WITH THEIR PEERS AND THEY ARE WITHIN THEIR PEER DATA. THE IPTH PATIENT SAMPLES WERE REPEATED AND THE RESULTS WERE AS EXPECTED. THE CUSTOMER DID NOT PROVIDED ANY DATA. THE CUSTOMER DECIDED TO CHANGE THEIR QC RANGES AND THEIR IPTH QC IS NOW WITHIN THEIR NEW RANGES. THE RESULTS FOR THE IPTH PATIENT SAMPLES ARE AS EXPECTED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE ADVIA CENTAUR IPTH IS NOT CLEARED FOR INTRA-OPERATIVE USE. THIS IS CONSIDERED OFF LABEL USE. THE IFU STATES IN THE INTENDED USE SECTION: "FOR IN VITRO DIAGNOSTIC USE IN THE QUANTITATIVE DETERMINATION OF INTACT PARATHYROID HORMONE (IPTH) IN EDTA PLASMA OR SERUM USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THIS ASSAY IS INTENDED TO BE USED TO AID IN THE DIFFERENTIAL DIAGNOSIS OF HYPERPARATHYROIDISM AND HYPOPARATHYROIDISM."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00043 ON FEBRUARY 29, 2016. ON 11/02/2016 CORRECTION: THE 510K NUMBER REPORTED IN THE INITIAL MDR WAS INCORRECT. THE CORRECT 510K NUMBER IS K133601.

    Description of Event or Problem · 1

    THE QUALITY CONTROL (QC) WAS OUT OF RANGE FOR ADVIA CENTAUR XP IPTH ASSAY. THE IPTH ASSAY IS BEING USED DURING INTRAOPERATIVE SURGERY. THE CUSTOMER RUNS PATIENT SAMPLES WHEN THE QC IS IN RANGE. THE DOCTORS HAVE NOT QUESTIONED ANY RESULTS. THERE HAS BEEN NO DELAY IN TESTING THAT HAS AFFECTED PATIENT CARE. THERE HAVE BEEN NO CORRECTED REPORTS. THE CUSTOMER HAS A BACKUP IPTH ASSAY WITH AN ALTERNATE METHOD. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IPTH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123445 ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 351

    Patients

    Seq Age Sex Outcome Treatment
    1