BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE INNOVIN

    MDR report key: 7666404 · Received July 6, 2018

    Report

    Report Number
    9610806-2018-00055
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Date of Event
    June 12, 2018
    Report Date
    July 6, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJS
    UDI-DI
    00842768003806
    PMA / PMN Number
    K974343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS INVESTIGATED THE CAUSE OF THE DISCORDANT PROTHROMBIN TIME (PT) / INTERNATIONAL NORMALIZED RATIO (INR) PATIENT RESULTS AND OUT OF RANGE PT QUALITY CONTROL (QC) GENERATED ON THE SYSMEX CA-620 SYSTEM AND DETERMINED THAT IT WAS DUE TO AN INCORRECT SETTING IN THE PT TEST PROTOCOL. CORRECTION TO THE TEST PROTOCOL RESOLVED THE QC ISSUE. THE DIFFERENCES OBSERVED FOR THE PT IN SECONDS BETWEEN THE 2 LABS CAN BE FURTHER EXPLAINED BY A DIFFERENCE IN THE SYSTEMS AND LOT NUMBERS OF REAGENTS BEING USED. THE INR WAS DEVELOPED TO CORRECT FOR THE VARIATION THAT CAN BE SEEN WITH PT VALUES REPORTED IN SECONDS BETWEEN DIFFERENT LOTS AND TYPES OF THROMBOPLASTIN PRODUCTS AND ANALYZER SYSTEMS. THE PT INRS WERE COMPARABLE BETWEEN THE 2 LABS. SIEMENS DETERMINED THAT THERE IS NO EVIDENCE OF A REAGENT, INSTRUMENT OR SOFTWARE MALFUNCTION. THE CAUSE OF THE DISCORDANT PT RESULTS WAS DUE TO A USE ERROR. THE CUSTOMER SERVICE ENGINEER (CSE) CHANGED THE PROTOCOL BACK TO "PT INN", ADJUSTED THE DETECTOR WELL TEMPERATURE AND RAN QUALITY CONTROL (QC) WITHOUT ISSUE. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE SYSTEMS AND REAGENTS ARE PERFORMING ACCORDING TO SPECIFICATIONS. MDR 9610806-2018-00056 WAS FILED FOR THE APTT PATIENT RESULTS USING DADE ACTIN FSL ACTIVATED PTT REAGENT LOT 556912.

    Description of Event or Problem · 1

    MULTIPLE DISCORDANT PROTHROMBIN TIME (PT) PATIENT SAMPLE RESULTS WERE GENERATED ON A SYSMEX CA-620 SYSTEM (SERIAL NUMBER (B)(4)) AND REPORTED TO PHYSICIANS FOR USING DADE INNOVIN LOT 539388 WHEN QUALITY CONTROL (QC) FOR PT WAS OUT OF RANGE. SOME PATIENT SAMPLES WERE RUN FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) USING DADE ACTIN FSL ACTIVATED PTT REAGENT LOT 556912. ON THE FOLLOWING DAY ((B)(6) 2018), ALL PATIENT SAMPLES WERE RETESTED AT AN ALTERNATE LABORATORY ON A SYSMEX CS-2500 SYSTEM, USING DADE INNOVIN LOT 549704 AND DADE ACTIN FSL ACTIVATED PTT REAGENT LOT 556904. NO CORRECTED REPORTS WERE ISSUED TO PHYSICIANS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PT/ INR PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508489 DADE INNOVIN DADE INNOVIN GJS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 539388 00842768003806

    Patients

    Seq Age Sex Outcome Treatment
    1