BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE INNOVIN

    MDR report key: 6948275 · Received October 13, 2017

    Report

    Report Number
    9610806-2017-00116
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    September 15, 2017
    Report Date
    November 10, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJS
    PMA / PMN Number
    K974343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) FILED THE INITIAL MDR 9610806-2017-00116 ON (B)(6) 2017. ADDITIONAL INFORMATION (OCTOBER 18, 2017): SIEMENS FURTHER INVESTIGATED THE LOG FILES FROM THE ATELLICA COAG 360 SYSTEM TO DETERMINE THE CAUSE OF THE DISCORDANT RESULTS. SIEMENS DETERMINED THAT THE SAMPLE VOLUME USED TO OBTAIN THE MEASUREMENTS AT 9:47:44 AND 9:58:15 WERE EXTRACTED FROM THE SAME ALIQUOT CUVETTE. THE LOW ABSORBANCE LEVEL OF THE MEASUREMENT AT 9:47:44 WAS POTENTIALLY CAUSED BY AIR WHEN THE SAMPLE WAS DISPENSED INTO THE MEASUREMENT CUVETTE. SIEMENS DETERMINED THAT THERE WAS FOAM IN THE SAMPLE TUBE AND THE FOAM MAY HAVE BEEN TRANSFERRED INTO THE ALIQUOT CUVETTE. THE MEASUREMENT VOLUME USED TO OBTAIN THE RESULTS AT 9:47:44 WAS PROBABLY LESS DUE TO THE FOAM IN THE ALIQUOT CUVETTE, POTENTIALLY RESULTING IN THE LOW PT% RESULT. THE MEASUREMENT VOLUME USED TO OBTAIN THE RESULTS AT 9:58:15 WAS PROBABLY SUFFICIENT AS IT IS ASSUMED THAT MOST OF THE FOAM WAS TRANSFERRED TO THE MEASUREMENT CUVETTE USED TO OBTAIN THE RESULTS AT 9:47:44. ADDITIONAL INFORMATION (OCTOBER 27, 2017): SIEMENS FURTHER ANALYZED THE LEVEL DETECTION VALUES OF THE FIRST ALIQUOT CUVETTE AND CONFIRMED THAT THERE WAS FOAM IN THE CUVETTE WITH THE PATIENT SAMPLE. THE CAUSE OF THE DISCORDANT RESULTS IS SPECIFIC TO THE PATIENT SAMPLE. SECTION HAS BEEN UPDATED TO REFLECT THIS INFORMATION. THE SYSTEM AND REAGENT ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS SYSTEM IS REQUIRED.

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST ANALYZED THE ATELLICA COAG 360 SYSTEM BACK UP FILES AND SIEMENS METHOD INTEGRATION SPECIALIST WAS DISPATCHED TO THE CUSTOMER'S SITE TO DETERMINE THE CAUSE OF THE DISCORDANT RESULTS. THE HSC SPECIALIST DETERMINED THAT THE INTERNAL QUALITY CONTROLS RECOVERED WITHIN EXPECTED RANGES AT THE TIME OF THE EVENT. THE HSC SPECIALIST DETERMINED THAT THE KINETICS OF THE AFFECTED SAMPLE WERE CORRECTLY EVALUATED BY THE SYSTEM AND OBSERVED THAT THE KINETICS OF THE AFFECTED MEASUREMENT HAD A LOWER ABSORBANCE LEVEL. THE LOWER ABSORBANCE LEVEL POTENTIALLY INDICATES THAT THERE WAS INSUFFICIENT SAMPLE MATERIAL IN THE MEASUREMENT CUVETTE. THE ALIQUOT OF THE AFFECTED PATIENT SAMPLE POTENTIALLY CONTAINED FOAM AND THIS POTENTIALLY CONTRIBUTED TO THE DISCORDANT RESULTS. THE CAUSE OF THE DISCORDANT RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE. THE RILIBÄK COMPLIANT DADE INNOVIN REAGENT WITH CATALOG NUMBER 10284500 DESCRIBED AND THE ATELLICA COAG 360 SYSTEM ARE NOT MARKETED IN THE UNITED STATES (US) AND THE PMA/510(K) NUMBER IS FOR THE US SPECIFIC DADE INNOVIN REAGENTS. THE DADE INNOVIN LOTS MARKETED IN THE US HAVE CATALOG NUMBERS 10445705, 10445706, AND 10445704.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW PROTHROMBIN TIME (PT) % RESULT AND A DISCORDANT, FALSELY ELEVATED PT RESULT WERE OBTAINED ON A PATIENT SAMPLE ON THE ATELLICA COAG 360 SYSTEM. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN SINCE THEY DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. THE SAME PATIENT SAMPLE WAS RERUN ON THE SAME SYSTEM TWICE, RESULTING IN HIGHER PT % RESULTS AND LOWER PT RESULTS. A CORRECT REPORT WAS PROVIDED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728673 DADE INNOVIN DADE INNOVIN GJS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN 539390A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR