BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3067025 · Received April 18, 2013

    Report

    Report Number
    2517506-2013-00117
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    July 24, 2012
    Report Date
    April 3, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    LCP
    PMA / PMN Number
    K102510
    Removal / Correction Number
    2517506-04-16-2013-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS CONFIRMED CUSTOMER COMPLAINTS OF A HIGHER FREQUENCY OF ABOVE ASSAY RANGE FLAGS WITH SEVERAL LISTED DIMENSION HB1C FLEX REAGENT CARTRIDGE LOTS. INVESTIGATION HAS SHOWN THAT THE HIGHER FREQUENCY OF FLAGS IS RELATED TO HIGHER RECOVERIES OF SAMPLE HEMOGLOBIN (HB) VALUES (HB > 25 G/DL OR >15 MMOL/L) WITH IMPACTED LOTS. THE HB VALUE IS USED TO CALCULATE THE FINAL HBA1C RATIO (% HBA1C -MMOL/MOL) RESULTS. RESULTS ARE SUPPRESSED (NOT REPORTED) WITH THE ABOVE ASSAY RANGE FLAG. AN URGENT MEDICAL DEVICE RECALL FOR THE HB1C FLEX REAGENT CARTRIDGE (DF105A) WAS ISSUED IN APRIL 2013 TO IMPACTED CUSTOMERS. THE COMMUNICATION (B)(4) INSTRUCTED CUSTOMERS TO IMMEDIATELY DISCARD ANY REMAINING INVENTORY OF THE AFFECTED LOTS OF DIMENSION HB1C (DF105A). SIEMENS PROVIDED A LOT NUMBER FOR LOTS BEYOND WHICH THE ISSUE WAS CORRECTED. USER FAILURE TO FOLLOW INSTRUCTIONS CONTRIBUTED TO THE PROBLEM. THE USER REPORTED A GREATER THAN VALUE OF >16% RATHER THAN RERUNNING THE SAMPLE AFTER A DILUTION. THE HB1C FLEX REAGENT CARTRIDGE INSTRUCTIONS FOR USE STATES: SAMPLES WITH RESULTS IN EXCESS OF 25 G/DL (15.5 MMOL/L) TOTAL HEMOGLOBIN OR 2.6 G/DL (1.6 MMOL/L) HBA1C ARE REPORTED AS ABOVE ASSAY RANGE AND SHOULD BE REPEATED ON DILUTION.

    Description of Event or Problem · 1

    A FALSELY ELEVATED HB1C RESULT WAS ERRONEOUSLY REPORTED ON TWO PATIENT SAMPLES. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS RE-RUN AND A LOWER RESULT WAS OBTAINED. THE ACCOUNT ADDITIONALLY COMPLAINED OF A HIGH FREQUENCY OF ABOVE ASSAY RANGE FLAGS FOR THE HB1C METHOD. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE ERRONEOUSLY REPORTED RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED HB1C RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168740 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM HEMOGLOBIN A1C KIT LCP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW GA3099

    Patients

    Seq Age Sex Outcome Treatment
    1