BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BCS(R) XP

    MDR report key: 4713395 · Received April 21, 2015

    Report

    Report Number
    9610806-2015-00008
    Event Type
    Malfunction
    Date Received
    April 21, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 1, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GKP
    PMA / PMN Number
    K970431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE REPORT OF THE DISCREPANT PROLONGED PT-INR RESULT HAS BEEN INVESTIGATED BY SIEMENS HEALTHCARE DIAGNOSTICS. THE CAUSE IS INCORRECT POSITIONING OF THE SAMPLE ON REPEAT ANALYSIS CAUSING A MISSING SAMPLE WHICH GENERATED A "NO REACTION" FLAG. THE CUSTOMER REPORTED A NUMERICAL RESULT EXCEEDING THE ASSAY RANGE. REVIEW OF THE DATA MAINTENANCE TOOL FILE IDENTIFIED THE PATIENT SAMPLE T9610 WAS LOADED ORIGINALLY AT (B)(6) 2015 AT 00:04 IN SAMPLE RACK 031004 IN POSITION 4. ALIQUOT 10827 WAS ASSIGNED FOR THE PT ASSAY. THE CUSTOMER RUNS THE PT ASSAY IN DUPLICATE. THE PTT AND FBG ANALYSIS WERE COMPLETED. PT ANALYSIS WAS INITIATED BUT ABORTED DUE TO QC OUT OF RANGE. THE SAMPLE RACK WAS EJECTED AND AT 00:21AM SAMPLE RACK 031004 WAS RELOADED; SAMPLE T9610 WAS NOW IN POSITION 3. ALIQUOT 10833 WAS ASSIGNED FOR THE PT ASSAY. THE PT ASSAY PROCESSED IN DUPLICATE AND DID NOT GENERATE NUMERICAL VALUES TO REPORT. THE AUTO ASSISTANT TRIGGERED A REFLEXIVE REQUEST TO REPEAT, AND THE REANALYSIS ALSO DID NOT PRODUCE NUMERICAL VALUES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE ANALZYER. THE PT-INR RESULTS IN QUESTION WERE FLAGGED WITH ANALYSIS SAMPLE REMARKS: RESULT DOUBTFUL; MEASUREMENT CURVE WITHOUT REACTION; AND MINIMUM DELTA A : INSUFFICIENT CHANGE IN SIGNAL. PER THE BCS XP INSTRUCTIONS FOR USE: DEFINITION OF MEASUREMENT CURVE WITHOUT REACTION: THE MEASUREMENT DID NOT DISPLAY A SPECIFIC COURSE OF REACTION, SO NO REACTION TIME COULD BE RECORDED "NO REACTION". IF THE FLAG "NO REACTION" APPEARS IN THE JOB LIST, THIS MEASUREMENT SHOULD BE REPEATED WITH THE SAME ASSAY. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATION. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    A DISCREPANT PROLONGED PROTHROMBIN TIME (PT-INR) RESULT WAS REPORTED ON A PATIENT SAMPLE. THE PATIENT RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AFTER THE PT RESULT WAS FOLLOWED UP WITH A FACTOR VII ANALYSIS. THE SAME SAMPLE IN THE PRIMARY TUBE WAS SENT TO A SISTER FACILITY TO HAVE A FACTOR VII RUN, AND THEY RAN A PT ALSO. THE PT VALUE WAS NORMAL RANGE. THE SAMPLE WAS SENT BACK TO THE ORIGINAL FACILITY AND RUN ON THE ALTERNATE BCS XP ANALYZER AND RECOVERED IN THE NORMAL REFERENCE RANGE. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE DISCREPANT PT-INR RESULT. CORRECTIVE FACTOR VII TREATMENT WAS ADMINISTERED. THE FACTOR VII TREATMENT WAS DISCONTINUED AFTER THE CORRECTED PT-INR RESULT WITHIN THE NORMAL RANGE WAS REPORTED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FVII TREATMENT. THE CUSTOMER CONFIRMED THERE WAS NO ALLERGIC REACTION AND NO CARDIAC ARREST. THE PATIENT DID NOT SUFFER ANY HARM FROM THE UNNECESSARY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263254 BCS(R) XP BCS(R) XP GKP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO