BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 INTACT PTH

    MDR report key: 6177848 · Received December 15, 2016

    Report

    Report Number
    2432235-2016-00764
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    September 6, 2016
    Report Date
    January 18, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    CEW
    PMA / PMN Number
    K013566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2016-00764 WAS FILED ON DECEMBER 15, 2016. ADDITIONAL INFORMATION (12/22/2016): A SIEMENS TECHNICAL OPERATIONS SPECIALIST PERFORMED IN-HOUSE TESTING ON KIT LOTS 321 AND 322 AND DETERMINED THAT THEY WERE PERFORMING AS PER MANUFACTURING SPECIFICATIONS. THE CUSTOMER WAS USING SERUM SAMPLES ON THE IMMULITE INSTRUMENT AND EDTA SAMPLES ON THE ALTERNATE PLATFORM. THE CUSTOMER USES SAME REFERENCE RANGE FOR EDTA AND SERUM SAMPLES. HOWEVER, AS PER IMMULITE 2000 INTACT PARATHYROID HORMONE INSTRUCTIONS FOR USE, THERE IS A CLEAR DIFFERENCE IN THE EXPECTED RANGES BETWEEN SERUM AND EDTA SAMPLES. ADDITIONAL INFORMATION (01/17/2017): A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE RESULTS OBTAINED ON KIT LOT 323. THE HSC SPECIALIST DETERMINED THAT THE RESULTS OBTAINED ON IMMULITE 2000 INSTRUMENT AND ALTERNATE PLATFORM WERE CLINICALLY EQUIVALENT. KIT LOT 323 IS PERFORMING AS INTENDED. THE CAUSE OF THE DISCORDANT, FALSELY LOW INTACT PARATHYROID HORMONE RESULTS ON MULTIPLE PATIENT SAMPLES IS UNKNOWN. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCORDANT, FALSELY LOW IPTH RESULTS ON MULTIPLE PATIENT SAMPLES IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE. ADDITIONALLY, UNIQUE IDENTIFICATION NUMBERS FOR: KIT LOT 321: (B)(4), KIT LOT 322: (B)(4), KIT LOT 323: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED DISCORDANT, FALSELY LOW INTACT PARATHYROID HORMONE (IPTH) RESULTS ON MULTIPLE PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING KIT LOTS 321, 322 AND 323. THE SAMPLES WERE REPEATED ON AN ALTERNATE PLATFORM, RESULTING HIGHER AND MATCHING THE CLINICAL PICTURE OF THE PATIENTS. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE REPEAT RESULTS OBTAINED ON THE ALTERNATE PLATFORM WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW IPTH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825945 IMMULITE 2000 INTACT PTH IMMULITE 2000 INTACT PTH CEW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 INTACT PTH 321, 322, 323

    Patients

    Seq Age Sex Outcome Treatment
    1