BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 4142602 · Received October 6, 2014

    Report

    Report Number
    2517506-2014-00224
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    May 22, 2014
    Report Date
    September 15, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    LCP
    PMA / PMN Number
    K102510
    Removal / Correction Number
    2517506-10-03-2014-008-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THAT THE DIMENSION® (B)(6) FLEX® REAGENT CARTRIDGE LOTS GA4266, BA4273, BA4280, BA4287, GA4301, GA4315, GC4322, GA4343, GA4350, GA4357, GA5013, AND GA5020 EXHIBIT A POSITIVE BIAS AVERAGING 0.4% HEMOGLOBIN A1C UNITS AND OCCASIONALLY UP TO 1.0% (B)(6)UNITS FOR PATIENT SAMPLES WHEN COMPARED TO THE NATIONAL GLYCOHEMOGLOBIN STANDARDIZATION PROGRAM (NGSP). QC SAMPLES MAY EXHIBIT A SIMILAR BIAS. THIS BIAS RESULTED IN COMPLAINTS FOR (B)(6) SURVEY FAILURES. IN THE URGENT MEDICAL DEVICE RECALL LETTER DATED (B)(4) 2014, #14-60 ISSUED TO CUSTOMERS WHO WERE SHIPPED THE IMPACTED LOTS, SIEMENS DIRECTED CUSTOMERS TO DISCONTINUE USE AND TO DISCARD THE IMPACTED LOTS. SIEMENS STATED IT WOULD REPLACE ANY UNUSED INVENTORY OF THE AFFECTED LOTS AT NO CHARGE WITH A NON-AFFECTED LOT.

    Description of Event or Problem · 1

    BIASED (B)(6) RESULTS WERE OBTAINED ON (B)(6) SURVEY SAMPLES. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE BIASED (B)(6) RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE BIASED (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624351 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM HEMOGLOBIN A1C KIT LCP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW GA4343

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability