BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® SYSTEM

    MDR report key: 4272226 · Received November 24, 2014

    Report

    Report Number
    2517506-2014-00359
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Date of Event
    September 14, 2014
    Report Date
    July 30, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CGX
    PMA / PMN Number
    K061238
    Removal / Correction Number
    2517506-2014-00050 SUPPL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN URGENT MEDICAL DEVICE CORRECTION (US) AND AN URGENT FIELD SAFETY NOTICE (OUS) DATED JULY 2015 WAS PROVIDED TO ALL CUSTOMERS WHO RECEIVED THE AFFECTED LOTS TO NOTIFY THEM OF THE FOLLOWING: - SIEMENS HAS CONFIRMED THAT THE DIMENSION CREA AND DIMENSION VISTA CREA MAY PRODUCE FALSELY DEPRESSED RESULTS UP TO -12.7% AND -22% RESPECTIVELY, FOR A CREATININE CONCENTRATION OF 1.5 MG/DL WHEN HEMOLYSIS EXCEEDS 200 MG/DL AND 300 MG/DL RESPECTIVELY. - CUSTOMERS WERE INSTRUCTED TO REVIEW THE LETTER WITH THEIR MEDICAL DIRECTOR. - CUSTOMERS WERE INSTRUCTED TO REVIEW AND UPDATE THEIR ESTABLISHED PROCEDURES FOR REPORTING CREA RESULTS FOR HEMOLYZED SAMPLES BASED ON THE INFORMATION IN THE LETTER. - CUSTOMERS WERE INSTRUCTED TO UPDATE THE H INDEX FOR HEMOLYSIS IF THAT FEATURE IS BEING USED ON THEIR SYSTEM. C&RR# 2517506-07152015-003-C.

    Additional Manufacturer Narrative · 1

    THE ACCOUNT ALLEGES THAT THE OBSERVED HEMOGLOBIN INTERFERENCE EXCEED THE CLAIM PROVIDED IN THE K1033 CREA REAGENT CARTRIDGE INSTRUCTIONS FOR USE. THE ISSUE IS UNDER INVESTIGATION BY (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: SIEMENS HEALTHCARE DIAGNOSTICS HAS CONDUCTED INVESTIGATIONS ON HEMOGLOBIN INTERFERENCE WITH THE DIMENSION VISTA® K1033 CREATININE (CREA) FLEX REAGENT CARTRIDGES. INVESTIGATIONS HAVE DETERMINED THAT DIMENSION VISTA® CREATININE (CREA) MAY PRODUCE DEPRESSED RESULTS UP TO 22% (OR APPROXIMATELY 0.3 MG/DL [27 MOL/L]) FOR A CREATININE RESULT AT 1.5 MG/DL [133 MOL/L] WHEN HEMOLYSIS EXCEEDS 200 MG/DL [0.12 MMOL/L] OF HEMOGLOBIN. PERCENT HEMOGLOBIN INTERFERENCE WITH DIMENSION VISTA® CREA IS DEPENDENT ON THE CREATININE CONCENTRATION; AT A CREATININE CONCENTRATION OF 5.0 MG/DL [442 MOL/L], HEMOGLOBIN INTERFERENCE AT CONCENTRATIONS UP TO A 1000 MG/DL [0.62 MMOL/L] IS < 10%. ALTERNATELY, WITH AN APPROXIMATE BIAS OF 0.3 MG/DL [27 MOL/L]), THE PERCENT HEMOGLOBIN INTERFERENCE MAY BE HIGHER AT LOW CREATININE CONCENTRATIONS (< 0.8 MG/DL [< 71 MOL/L]). DEPRESSED CREATININE RESULTS DUE TO HEMOLYSIS AS DESCRIBED ABOVE MAY LEAD TO INCREASED ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) VALUES AND/OR POTENTIAL MISINTERPRETATION OF ACUTE KIDNEY INJURY (AKI). THE POTENTIAL FOR INJURY IS REMOTE DUE TO CONTINUED MONITORING, ADDITIONAL DIAGNOSTIC TESTING AND CORRELATION TO PATIENT HISTORY AND PRESENTATION. DEPRESSED CREATININE RESULTS DUE TO HEMOLYSIS AS DESCRIBED ABOVE WOULD NOT BE EXPECTED TO SIGNIFICANTLY IMPACT MEDICAL DECISIONS WHEN USING THIS ASSAY. HOWEVER, SIEMENS HEALTHCARE DIAGNOSTICS IS ISSUING AN URGENT MEDICAL DEVICE CORRECTION (US) AND AN URGENT FIELD SAFETY NOTICE (OUS) DATED JULY 2015 ALERTING CUSTOMERS THAT THEY SHOULD REVIEW THEIR CURRENTLY ESTABLISHED PROCEDURE FOR REPORTING CREA RESULTS FOR HEMOLYZED SAMPLES AND UPDATE PROCEDURES AS NECESSARY FOR THE REVISED INTERFERENCE INFORMATION DESCRIBED IN THE COMMUNICATION.

    Description of Event or Problem · 1

    AN ACCOUNT COMPLAINED OF FALSELY DEPRESSED CREATININE (CREA) RESULTS ON A HEMOLYZED PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE ACCOUNT RAN NEW SAMPLES DRAWN THE NEXT DAY FROM THE SAME PATIENTS (WHICH HAD LOWER LEVELS OF HEMOGLOBIN) AND A HIGHER RESULTS WAS OBTAINED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE DEPRESSED CREA RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DEPRESSED CREA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761238 DIMENSION VISTA® SYSTEM CREATININE FLEX® REAGENT CARTRIDGE CGX SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1