BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

    MDR report key: 5913568 · Received August 30, 2016

    Report

    Report Number
    1219913-2016-00152
    Event Type
    Malfunction
    Date Received
    August 30, 2016
    Date of Event
    June 1, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT IPTH RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE IFU STATES UNDER 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. IT SHOULD BE NOTED THAT SOME OVERLAP OF INTACT PTH VALUES DOES EXIST FROM PATIENTS WITH VARIOUS PARATHYROID DISORDERS. THE TYPE OF SPECIMEN USED (SERUM OR EDTA PLASMA) MAY INFLUENCE INTACT PTH MEASUREMENTS.14,15 DURING ROUTINE MONITORING OF IPTH LEVELS, TO AVOID BIAS IN THE RESULTS, USE THE SAME SPECIMEN TYPE THROUGHOUT THE MONITORING PERIOD." LOT# 360 EXPIRATION DATE: 12/08/2016, MANUFACTURE DATE: 10/08/2015. LOT# 361 EXPIRATION DATE: 04/25/2017, MANUFACTURE DATE: 02/25/2016.

    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

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00152 ON AUGUST 30, 2016. ON 10/18/2016 ADDITIONAL INFORMATION: THE CALCIUM, VITAMIN D AND PHOSPHORUS LEVELS WERE PROVIDED FOR TWO OF THE PATIENT SAMPLES. FOR THE (B)(6) 2016 SAMPLE, SID (B)(6): CALCIUM: 8.4 MG/DL, PHOSPHORUS: 6.2 MG/DL. NO VITAMIN D RESULTS WERE FOUND FOR THIS SID. FOR THE (B)(6) 2016 SAMPLE: CALCIUM: 9.0 MG/DL, PHOSPHORUS: 5.3 MG/DL, VITAMIN D: 9.0 NG/ML. THE PATIENT SAMPLE WITH THE 1:5 DILUTION RESULT OF 2313 PG/ML WAS STORED IN THE REFRIGERATOR FOR FIVE DAYS. PER THE IFU, THE EDTA SAMPLES CAN BE STORED AT 4°C FOR 72 HOURS ONLY. THE SAMPLE WAS UNSUITABLE FOR TESTING AS STABILITY OF THE SAMPLE WAS BEYOND THE RECOMMENDATION AS STATED IN THE IFU. THE SAMPLE THAT WAS SENT OUT TO A REFERENCE LABORATORY FOR TESTING WAS SERUM AND HAD THE VALUE OF 580 PG/ML WHICH WAS LOWER THAN THE EDTA SAMPLE. THE METHOD USED FOR TESTING FOR THE SEND OUT SAMPLE WAS UNKNOWN. THE VARIABILITY BETWEEN THE RESULTS MAY BE ATTRIBUTED TO THE DIFFERENT SAMPLE TYPE (EDTA VERSUS SERUM), THE DIFFERENCES IN ANTIBODY EPITOPES OR THE DIFFERENCE IN STANDARDIZATIONS BETWEEN MANUFACTURES. BOTH IPTH VALUES WERE ABNORMAL FOR THIS PATIENT SAMPLE WHEN EVALUATED WITH THE SEND OUT METHOD AND THE ADVIA CENTAUR METHOD. THE CUSTOMER DOES NOT HAVE ACCESS TO THE CLINICAL HISTORY OF THE PATIENT. ZEMPLAR (PARICALCITOL) IS A MAN-MADE FORM OF VITAMIN D. VITAMIN D AIDS IN THE ABSORPTION OF CALCIUM FROM THE STOMACH AND FOR THE FUNCTIONING OF CALCIUM IN THE BODY. WITHOUT THE CLINICAL HISTORY OR MEDICATIONS NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED. HOWEVER SIEMENS CANNOT RULE OUT THE POSSIBILITY OF DRUG INTERACTIONS WHICH MAY IMPAIR WITH INTESTINAL ABSORPTION OF FAT-SOLUBLE VITAMINS AND THUS INTERFERING WITH THE ABSORPTION OF ZEMPLAR AS THE REASON IPTH VALUES WERE NOT DECREASING. THE CAUSE FOR THE DISCORDANT IPTH RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. ON 11/02/2016 CORRECTION: THE 510K NUMBER REPORTED IN THE INITAL MDR WAS INCORRECT. THE CORRECT 510K NUMBER IS K133601. THE IFU STATES IN THE SPECIMEN COLLECTION AND HANDLING SECTION: "CORRECT HANDLING OF PATIENT SAMPLES IS CRITICAL TO ENSURE THE INTEGRITY OF THE INTACT PTH MOLECULE. INTACT PTH HAS BEEN DEMONSTRATED TO BE LABILE AND IS SUSCEPTIBLE TO FRAGMENTATION. THIS INSTABILITY DEPENDS ON BOTH TIME AND TEMPERATURE. PATIENT SAMPLE STABILITY IS OUTLINED IN THE FOLLOWING TABLE: (B)(6).

    Description of Event or Problem · 1

    FALSELY HIGH ADVIA CENTAUR XP IPTH RESULTS WERE OBTAINED FOR SAMPLES FROM THE SAME PATIENT. THE RESULTS WERE QUESTIONED BY THE PHYSICIAN SINCE THE RESULTS SEEM TO BE GETTING HIGHER. THE CUSTOMER STATES THE PATIENT HAS BEEN ON THE DRUG ZEMPLAR (PARICALCITOL) WHICH WORKS BY TELLING THE PARATHYROID GLANDS TO STOP PRODUCING TOO MUCH PTH. ONE OF THE PATIENT SAMPLES WAS SENT TO THE QUEST LABORATORY TO BE TESTED. THE RESULT WAS LOWER. PATIENT TAKING ZEMPLAR (PARICALCITOL). 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
    565867 ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 360 AND 361

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR