BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY

    MDR report key: 6865361 · Received September 14, 2017

    Report

    Report Number
    1219913-2017-00193
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    July 15, 2017
    Report Date
    November 8, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT IPTH RESULT IS UNKNOWN. THE CUSTOMER WILL SEND THE PATIENT SAMPLE FOR FURTHER TESTING AND INVESTIGATION. 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. HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS. PATIENTS ROUTINELY EXPOSED TO ANIMALS OR TO ANIMAL SERUM PRODUCTS CAN BE PRONE TO THIS INTERFERENCE AND ANOMALOUS VALUES MAY BE OBSERVED. ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS." MDR 1219913-2017-00203, 1219913-2017-00204 AND 1219913-2017-00205 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00193 ON SEPTEMBER 14, 2017. 09/20/2017 ADDITIONAL INFORMATION: THE CUSTOMER SENT THE PATIENT SAMPLE FOR FURTHER TESTING AND EVALUATION. THE SAMPLE VOLUME FOR THIS SAMPLE WAS 600 UL. THE SAMPLE WAS EVALUATED ON THE ADVIA CENTAUR IPTH ASSAY WITH REAGENT LOT 366 AND 369. THE RESULTS OBSERVED WERE ABOVE THE ASSAY RANGE (>1900 PG/ML). SERIAL DILUTIONS WERE PERFORMED ON THE SAMPLE WHICH GENERATED ASPIRATION ERRORS DUE TO LOW SAMPLE VOLUME SIEMENS IS UNABLE TO PERFORM ADDITIONAL TESTING ON THE SAMPLE DUE TO THE LIMITED SAMPLE VOLUME. . RESULTS (PG/ML): NEAT 1:2 1:4 1:8 REP 1 >1900.0 ASP. ERROR ASP. ERROR < CONC RANGE REP 2 >1900.0 MEAN >1900. THE CUSTOMER PROVIDED RESULTS OF THE PATIENT SAMPLE A SAMPLE SENT TO ANOTHER LABORATORY FOR IPTH TESTING USING AN ALTERNATE METHOD. THE RESULT WAS 14 PG/ML (REFERENCE RANGE 14-72 PG/ML). THE CUSTOMER ALSO PROVIDED RESULTS OF SAMPLE SENT IN TO ANOTHER LABORATORY BY PHYSICIAN FOR IPTH TESTING, METHOD IS UNKNOWN. THE RESULT WAS 15PG/ML. THE CUSTOMER HAS A 1ML EDTA SAMPLE FROM THE SAME PATIENT TO SEND FOR FURTHER TESTING. THE SAMPLE WAS RUN FOR IPTH ON THE ADVIA CENTAUR AND THE RESULT WAS 1634.7. THE SAMPLE WAS ALIQUOTED AND FROZEN. THE PATIENT SAMPLE WAS TESTED ON REAGENT LOT 370 AND CAL LOT C5674. THE INITIAL RESULT WAS >1900 PG/ML. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. MDR 1219913-2017-00203 SUPPLEMENTAL REPORT 1, 1219913-2017-00204 SUPPLEMENTAL REPORT 1 AND 1219913-2017-00205 SUPPLEMENTAL REPORT 1 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00193 ON SEPTEMBER 14, 2017. SIEMENS FILED THE MDR 1219913-2017-00193 SUPPLEMENTAL REPORT 1 ON OCTOBER 13, 2017. 10/26/2017 ADDITIONAL INFORMATION: THE CUSTOMER SENT THE 1ML EDTA SAMPLE FROM THE SAME PATIENT FOR FURTHER TESTING IN-HOUSE. THE SAMPLE WAS TESTED IN SINGLET ON THE ADVIA CENTAUR XP AND IMMULITE 2000 XPI PLATFORMS. HBT (HETEROPHILIC BLOCKING TUBE) TESTING WAS ALSO PERFORMED ON THE PATIENT SAMPLE. RESULTS (PG/ML): ADVIA CENTAUR XP WITH LOT 370. NEAT: >1900, HBT: >1900. IMMULITE 2000 XPI WITH LOT 326 NEAT: 4.11, HBT: <3.00. IN CONCLUSION SIEMENS WAS ABLE TO VERIFY THE HIGHER RESULT ON THE ADVIA CENTAUR XP WHICH FIT THE CLINICAL PICTURE OF THE PATIENT. SIEMENS WAS UNABLE TO PROVIDE A CAUSE AS TO WHY THE INITIAL SAMPLE (1ST SAMPLE) WAS UNABLE TO BE DILUTED. THE IMMULITE VALUES DO NOT FIT THE CLINICAL PICTURE OF THE PATIENT. BASED ON THE INVESTIGATION IT APPEARS THAT THE MOST LIKELY REASON FOR THE DISCORDANT RESULT IS A SAMPLE SPECIFIC ISSUE DUE TO SOME UNIDENTIFIED INTERFERENCE. AS THE BLOCKING TUBE TESTING WAS PERFORMED A NON-SPECIFIC INTERFERENT CAN BE RULED OUT. HOWEVER, THERE APPEARS TO BE ANOTHER TYPE OF INTERFERENCE. IT IS POSSIBLE THAT THE INTERFERING SUBSTANCE IS A MEDICATION THE PATIENT IS TAKING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 1219913-2017-00203 SUPPLEMENTAL REPORT 2, 1219913-2017-00204 SUPPLEMENTAL REPORT 2 AND 1219913-2017-00205 SUPPLEMENTAL REPORT 2 WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A DISCORDANT ADVIA CENTAUR XP IPTH RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS GREATER THAN 1900. THE SAMPLE WAS DILUTED AND A VALID RESULT COULD NOT BE OBTAINED. THE DOCTOR WAS EXPECTING TO SEE SIMILAR RESULTS TO RECENT PATIENT HISTORY. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THESE DISCORDANT IPTH RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647586 ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 10027366 00630414579153

    Patients

    Seq Age Sex Outcome Treatment
    1