BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP INTACT PTH (IPTH) ASSAY

    MDR report key: 2424137 · Received January 20, 2012

    Report

    Report Number
    1219913-2012-00017
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    August 4, 2010
    Report Date
    August 5, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    PMA / PMN Number
    K020217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE ELEVATED ADVIA CENTAUR CP IPTH RESULTS WHEN COMPARED TO PATIENT'S CLINICAL PICTURE IS UNKNOWN. THE QUALITY CONTROL RESULTS WERE ALL WITHIN THE EXPECTED RANGES AND NO OTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE CUSTOMER DECLINED A FIELD SERVICE VISIT. QC LEVEL: L1; RESULTS: 20.4; RANGES: 17-35; REPEAT QC RESULTS (POST OPERATIVE): 20.1. QC LEVEL: L2; RESULTS: 198.7; RANGES: 153-283; REPEAT QC RESULTS (POST OPERATIVE): 194.9. QC LEVEL: L3; RESULTS: 684.5; RANGES: 554-1030; REPEAT QC RESULTS (POST OPERATIVE): 688.5. THE INSTRUCTION FOR USE (IFU) INTENDED USE STATES THE FOLLOWING: " FOR IN VITRO DIAGNOSTICS USE IN THE QUANTITATIVE DETERMINATION OF INTACT PARATHYROID HORMONE (IPTH) IN EDTA PLASMA OR SERUM USING THE ADVIA CENTAUR SYSTEM. THIS ASSAY IS INTENDED TO BE USED TO AID THE DIFFERENTIAL DIAGNOSIS OF HYPERPARATHYROIDISM, HYPOPARATHYROIDISM, OR HYPERCALCEMIA OF MALIGNANCY." THE INSTRUCTIONS FOR USE (IFU) LIMITATION SECTION STATES THE FOLLOWING: " MEASUREMENT OF INTACT PTH IS USEFUL IN DIFFERENTIATING BETWEEN HYPERCALCEMIA DUE TO HYPERPARATHYROIDISM AND HYPERCALCEMIA OF MALIGNANCY. HOWEVER, THE ASSAY IS NOT INTENDED AS AND SHOULD NOT BE RELIED UPON AS A DIAGNOSTIC INDICATOR OF MALIGNANCY". NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A FALSELY ELEVATED ADVIA CENTAUR CP IPTH TEST RESULT WAS OBTAINED BY THE CUSTOMER AND CONSIDERED DISCORDANT WHEN COMPARED TO THE PATIENT'S CLINICAL PICTURE. A POST OPERATIVE FOLLOW UP SAMPLE WAS DRAWN AT A LATER DATE AND THE RESULT WAS AS EXPECTED. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IPTH TEST RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CP INTACT PTH (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 156

    Patients

    Seq Age Sex Outcome Treatment
    1