BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2973896 · Received February 22, 2013

    Report

    Report Number
    2517506-2013-00072
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 30, 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
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS CONFIRMED CUSTOMER COMPLAINTS OF A HIGHER FREQUENCY OF "ABOVE ASSAY RANGE" FLAGS WITH SEVERAL LISTED DIMENSION VISTA HBAIC 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 HBA1C FLEX® REAGENT CARTRIDGE (K3105A) WAS ISSUED IN (B)(4) 2013 TO IMPACTED CUSTOMERS. THE COMMUNICATION 13-18 INSTRUCTED CUSTOMERS TO IMMEDIATELY DISCARD ANY REMAINING INVENTORY OF THE AFFECTED LOTS OF DIMENSION HBA1C (K3105A). SIEMENS PROVIDED A LOT NUMBER FOR LOTS BEYOND WHICH THE ISSUE WAS CORRECTED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED HBA1C RESULTS IS USER ERROR. THE ACCOUNT FAILED TO FOLLOW THE IFU INSTRUCTIONS TO REPEAT A FLAGGED ABOVE ASSAY RANGE RESULT WITH A DILUTION. THE HBA1C FLEX(R) REAGENT CARTRIDGE INSTRUCTIONS FOR USE INSTRUCTS CUSTOMERS THAT SAMPLES IN EXCESS OF 16% HBA1C OR 25 G/DL HEMOGLOBIN SHOULD BE REPEATED ON DILUTION. DUE TO A HEMOGLOBIN RESULT WHICH WAS ABOVE 25G/DL, THE HBA1C RESULT WAS FLAGGED BUT THE CUSTOMER REPORTED A VALUE OF GREATER THAN 13% WHICH WAS THEIR INDIVIDUAL LABORATORY UPPER RANGE LIMIT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED HBA1C RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A REDRAW SAMPLE WAS RUN SIX DAYS LATER AND A LOWER RESULT WAS OBTAINED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED HBA1C RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78077 DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM HEMOGLOBIN A1C KIT LCP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 12282AA

    Patients

    Seq Age Sex Outcome Treatment
    1