BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY

    MDR report key: 6762154 · Received August 2, 2017

    Report

    Report Number
    1219913-2017-00172
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 10, 2017
    Report Date
    August 2, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    UDI-DI
    00630414579153
    PMA / PMN Number
    K133601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RECEIVED THE MCMS (MASTER CURVE MATERIAL) TO RUN. THE MCMS WERE RUN AND ALL THE LEVELS WERE WITHIN RANGE. MCM LOT# 72254, TESTED WITH REAGENT LOT 368. MCM1: OBSERVED: 0.6, TARGET: 0, RANGES: < 7.5, MCM2: OBSERVED: 26.8, TARGET: 28.1, RANGES: 18.3 - 37.9, MCM3: OBSERVED: 49.9, TARGET: 50.6, RANGES: 32.9 - 68.3, MCM4: OBSERVED: 138.1, TARGET: 132, RANGES: 92.4 ¿ 172, MCM5: OBSERVED: 347, TARGET: 345, RANGES: 242 ¿ 449, MCM6: OBSERVED: 868 TARGET: 866, RANGES: 606 ¿ 1126, MCM7: OBSERVED: >1900, TARGET: 2493, RANGES: >1900. THE CUSTOMER RAN THE QUALITY CONTROL WITH REAGENT LOT 368 AND ALL THE LEVELS WITHIN RANGES. QC LOT 60211: OBSERVED: 8.33, RANGES: 6.22 - 15.22, QC LOT 60212: OBSERVED: 93.88, RANGES: 77.35 - 121.03, QC LOT 63213: OBSERVED: 341.4, RANGES: 290.4 -386.4. SIEMENS REVIEWED IN HOUSE DATA TO RELEASE REAGENT LOT 368. THE REAGENT LOT 368 RECOVERED SLIGHTLY LOWER THAN REAGENT LOT 366. ALL THE SAMPLES WERE WITHIN MANUFACTURER'S ACCEPTABLE RANGES. THE CUSTOMER QUALITY CONTROL WAS WITHIN RANGE. THE MASTER CURVE MATERIAL RESULTS PROVIDED WERE ALL WITHIN RANGE. SIEMENS DOES NOT CONFIRM A PRODUCT NONCONFORMANCE ISSUE. THE CAUSE FOR THE DISCORDANT IPTH RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. 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: TEMPERATURE: ROOM TEMPERATURE, EDTA PLASMA STABILITY: 8 HOURS, SERUM STABILITY: 4 HOURS; 4 DEGREE C, 72 HOURS, 48 HOURS; -70 DEGREE C, 8 MONTHS, NOT TESTED". 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."

    Description of Event or Problem · 1

    A FALSE LOW ADVIA CENTAUR XP IPTH RESULT WAS OBTAINED FOR A PATIENT SAMPLE DURING A LOT TO LOT CORRELATION. THE CORRELATION WAS BETWEEN REAGENT LOT 366 AND 368. LOT 368 WAS READING LOWER THAN LOT 366. THE PATIENT RESULT FROM LOT 368 WAS NOT REPORTED. PATIENT TREATMENT WAS NOT 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
    542864 ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 056368 00630414579153

    Patients

    Seq Age Sex Outcome Treatment
    1