BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® SYSTEM

    MDR report key: 4889369 · Received July 2, 2015

    Report

    Report Number
    2517506-2015-00153
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    April 9, 2014
    Report Date
    July 30, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CGX
    PMA / PMN Number
    K925668
    Removal / Correction Number
    2517506-07152015-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL MDR SUBMITTED 2015-07-02. 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

    SIEMENS HEALTHCARE DIAGNOSTICS HAS CONDUCTED INVESTIGATIONS ON HEMOGLOBIN INTERFERENCE WITH THE DIMENSION® DF33A (CREA) FLEX REAGENT CARTRIDGES. INVESTIGATIONS HAVE DETERMINED THAT DIMENSION® CREATININE (CREA) MAY PRODUCE DEPRESSED RESULTS UP TO 12.7% (OR APPROXIMATELY 0.2 MG/DL [18 UMOL/L]) FOR A CREATININE RESULT AT 1.5 MG/DL [133 UMOL/L] WHEN HEMOLYSIS EXCEEDS 300 MG/DL [0.19 MMOL/L] OF HEMOGLOBIN. PERCENT HEMOGLOBIN INTERFERENCE WITH DIMENSION® CREA IS DEPENDENT ON THE CREATININE CONCENTRATION; AT A CREATININE CONCENTRATION OF 5.0 MG/DL [442 UMOL/L], HEMOGLOBIN INTERFERENCE AT CONCENTRATIONS UP TO A 1000 MG/DL [0.62 MMOL/L] IS < 10%. ALTERNATELY, WITH AN APPROXIMATE BIAS OF 0.2 MG/DL [18 UMOL/L]), THE PERCENT HEMOGLOBIN INTERFERENCE MAY BE HIGHER AT LOW CREATININE CONCENTRATIONS (< 0.8 MG/DL [< 71 UMOL/L]). 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 HEMOLYZED PATIENT SAMPLES. PATIENT RESULTS WERE FLAGGED BELOW ASSAY RANGE AND WERE NOT REPORTED. THE SAMPLES WERE REPEATED ON AN ALTERNATE METHODOLOGY AND RESULTS WERE OBTAINED WITHIN REPORTABLE RANGES. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE BELOW ASSAY RANGE, DEPRESSED CREA RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DEPRESSED CREA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430054 DIMENSION® SYSTEM CREATININE FLEX® REAGENT CARTRIDGE CGX SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1