BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

    MDR report key: 5727715 · Received June 15, 2016

    Report

    Report Number
    1219913-2016-00108
    Event Type
    Malfunction
    Date Received
    June 15, 2016
    Date of Event
    May 18, 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
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00108 ON JUNE 15, 2016. ON 06/20/2016 ADDITIONAL INFORMATION: THE PATIENT DATA WAS PROVIDED FOR THREE PATIENTS. IPTH RESULTS (PG/ML): SID: (B)(6), INITIAL RESULT: 103, CORRECTED RESULT: 75.6; (B)(6), 287.9, 215.6; (B)(6), 39.1, 25.6. THE CUSTOMER IS USING THE CORRECT COMBINATION OF REAGENT/CALIBRATOR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    ON 11/02/2016 CORRECTION:THE 510K NUMBER REPORTED IN THE INITAL MDR WAS INCORRECT. THE CORRECT 510K NUMBER IS K133601.

    Additional Manufacturer Narrative · 1

    THE QUALITY CONTROL (QC) WAS OUT OF RANGE FOR ADVIA CENTAUR XP IPTH ASSAY WHEN THE CUSTOMER REPORTED THE RESULTS. THE CUSTOMER STATED THAT 14 PATIENT RESULTS WERE RUN OVER A TWO DAY PERIOD USING THE INCORRECT IPTH REAGENT/CALIBRATOR COMBINATION. THE CUSTOMER REPEATED THE TESTING AND CORRECTED 6 PATIENT RESULTS USING THE CORRECT IPTH REAGENT/CALIBRATOR COMBINATION. THE QC WAS IN RANGE WITH THE CORRECT IPTH REAGENT/CALIBRATOR COMBINATION. THE CAUSE OF THE DISCORDANT IPTH RESULTS IS USE ERROR. THE CUSTOMER VERIFIED THAT THE NOTECARDS IN THE KITS WERE RECEIVED. THE NOTECARDS REFER THE TO CUSTOMER BULLETIN 11221394 REV. B WHICH EXPLAINS THE CALIBRATOR/REAGENT COMPATIBILITY FOR REAGENT LOTS 056360 AND ABOVE WITH CALIBRATOR LOTS C5670 AND ABOVE. THE CUSTOMER HAS RECEIVED CUSTOMER BULLETIN 11221394 REV. B. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE LIMITATIONS SECTION: "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 IFU STATES IN THE TAKING CORRECTIVE ACTION SECTION: "IF THE QUALITY CONTROL RESULTS DO NOT FALL WITHIN THE EXPECTED VALUES OR WITHIN THE LABORATORY'S ESTABLISHED VALUES, DO NOT REPORT RESULTS. TAKE THE FOLLOWING ACTIONS: DETERMINE AND CORRECT THE CAUSE OF THE UNACCEPTABLE CONTROL RESULTS: VERIFY THAT THE MATERIALS ARE NOT EXPIRED. VERIFY THAT REQUIRED MAINTENANCE WAS PERFORMED. VERIFY THAT THE ASSAY WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE. RERUN THE ASSAY WITH FRESH QUALITY CONTROL SAMPLES, AND CONFIRM THAT QUALITY CONTROL RESULTS ARE WITHIN ACCEPTABLE LIMITS BEFORE RUNNING PATIENT SAMPLES. IF THE QUALITY CONTROL RESULTS ARE NOT WITHIN ACCEPTABLE LIMITS, RECALIBRATE THE ASSAY, AND REPEAT ABOVE STEP. IF NECESSARY, CONTACT YOUR LOCAL TECHNICAL SUPPORT PROVIDER OR DISTRIBUTOR FOR ASSISTANCE. REPEAT TESTING OF PATIENT SAMPLES BEFORE REPORTING RESULTS. PERFORM CORRECTIVE ACTIONS IN ACCORDANCE WITH YOUR ESTABLISHED LABORATORY PROTOCOL."

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XP IPTH RESULTS WERE OBTAINED ON SAMPLES FROM SEVERAL PATIENTS. THE DISCORDANT RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN. REPEAT TESTING WAS PERFORMED ON THE SAME INSTRUMENT AND THE RESULTS WERE >30% DIFFERENT. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IPTH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380803 ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 360

    Patients

    Seq Age Sex Outcome Treatment
    1