BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX CA-500 SERIES ANALYZER

    MDR report key: 3777889 · Received April 22, 2014

    Report

    Report Number
    3009711478-2014-00010
    Event Type
    Other
    Date Received
    April 22, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 24, 2014
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKP
    PMA / PMN Number
    K031377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATOR PERFORMED REPEAT ANALYSIS ON SEVEN PATIENT RESULTS ANALYZED ON (B)(6) 2014 AFTER ANALYZER WAS SERVICED BY A SIEMENS FSE. THE OPERATOR DID NOT PROVIDE REPEAT ANALYSIS DATA; HOWEVER STATED THE RESULTS MATCHED INITIAL RESULTS. THE OPERATOR REVIEWED PRIOR PATIENT DATA ON SAMPLES WITH DELTA CHECKS FROM (B)(6) 2014 TO (B)(6) 2014, NO DOCTORS QUESTIONED THE RESULTS AND CORRECTED REPORTS WERE NOT ISSUED. THE USER DECIDED THIS IS EVIDENCE OF NO ERRONEOUS RESULTS BEING REPORTED. THE USER REPORTED NO IMPACT TO PATIENT MANAGEMENT. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION. ANALYZER PRINTOUTS FROM THESE SAMPLES OR THE ERROR LOG FROM THE TIME OF THE EVENT WERE NOT PROVIDED; ERRONEOUS RESULTS COULD NOT BE CONFIRMED. THE (B)(4) OPERATORS MANUAL CAUTIONS: "THIS INSTRUMENT IS USED FOR SCREENING PATIENT SAMPLES. WHEN MAKING CLINICAL JUDGMENT BASED ON ANALYSIS RESULTS, THE DOCTOR MUST ALSO CONSIDER CLINICAL CONDITIONS AND OTHER INSPECTION RESULTS FOR AN OVERALL JUDGMENT." THE SAMPLE PROBE CONTROLS THE AMOUNT OF SAMPLE DELIVERED TO THE REACTION TUBE AND RESULTS, IT IS POSSIBLE PATIENT RESULTS WERE AFFECTED. THE OPERATOR WAS ALERTED TO A PROBLEM WITH THE ANALYZER'S HYDRAULICS FROM THE QC RESULTS, BUT IGNORED THE LOW DATA AND CONTINUED TO USE THE ANALYZER FOR PATIENT TESTING. THIS EVENT WILL BE REPORTED AS IT CANNOT BE CONFIRMED RESULTS WERE ACCURATE WHEN RELEASED TO CLINICIANS.

    Description of Event or Problem · 1

    SIEMENS HEALTHCARE DIAGNOSTICS WAS INFORMED ON (B)(6) 2014 BY A SIEMENS FIELD SERVICE ENGINEER (FSE) IN WHICH INCORRECT RESULTS FOR PROTHROMBIN TIME (PT), AND INTERNATIONAL NORMALIZED RATIO (INR) MAY HAVE BEEN GENERATED. THE PT REAGENT IN USE WAS INNOVIN LOT 539202 EXPIRATION DATE WAS NOT PROVIDED. QC SAMPLES ANALYZED FELL OUTSIDE OF ACCEPTABLE RANGE FOR QC, CI-TROL, LEVEL 2 LOT 548227A. THE QC HAD BEEN OUT OF RANGE FOR SEVERAL DAYS DURING A THREE WEEK PERIOD FROM (B)(6) 2014 THROUGH (B)(6) 2014. THE QC DATA PROVIDED DID NOT INCLUDE THE DATES QC WAS ANALYZED. THE OPERATOR CONTINUED TO PROCESS PATIENT SAMPLES AND REPORT RESULTS. ON (B)(6) 2014 THE FSE IDENTIFIED PT IMPRECISION AND REPLACED SAMPLE PROBE AND WATER FILTER. ALIGNMENTS WERE PERFORMED AND PRECISION WAS VERIFIED. QC WAS ANALYZED AND WITHIN ACCEPTABLE RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244654 SYSMEX CA-500 SERIES ANALYZER AUTOMATED BLOOD COAGULATION ANALYZER GKP SYSMEX CORPORATION CA-560

    Patients

    Seq Age Sex Outcome Treatment
    1 Other