BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3171876 · Received June 17, 2013

    Report

    Report Number
    2517506-2013-00290
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    February 3, 2013
    Report Date
    May 24, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JIT
    PMA / PMN Number
    K970336
    Removal / Correction Number
    2517506-6-5-2013-007C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE BIASED LOW MMB RESULTS IS A CALIBRATOR DISSOLUTION ISSUE. THE ACCOUNT NOTED POOR DISOLUTION OF THE LYOPHILIZED CALIBRATOR LOT 2GD053. SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS CONFIRMED CUSTOMER COMPLAINTS OF MMB CALIBRATOR, RC420, LOTS 2GD053, 2KD024 AND 3AD051, NOT BEING FULLY DISSOLVED AFTER THE STATED TIME IN THE PRODUCT INSTRUCTIONS FOR USE. THE FREQUENCY OF THIS OCCURRENCE IS LOW BUT IF IT OCCURS, GEL-LIKE CLUMPS MAY BE OBSERVED. AN URGENT MEDICAL DEVICE CORRECTION (UMDC) FOR THE MMB CALIBRATOR RC420 WAS ISSUED IN MAY 2013 TO IMPACTED CUSTOMERS. THE COMMUNICATION, (B)(4), PROVIDED CUSTOMERS WITH A WORKAROUND FOR THE IMPACTED LOTS. CUSTOMERS WERE NOTIFIED THAT THE MMB CALIBRATOR CAN TOLERATE EXTENDED RECONSTITUTION TIME (UP TO FOUR HOURS) AND STILL MEET PERFORMANCE SPECIFICATIONS. THEY WERE NOTIFIED THAT UNTIL A PERMANENT SOLUTION TO THE ISSUE IS IDENTIFIED, THEY ARE TO FOLLOW THE CALIBRATOR PREPARATION INSTRUCTIONS PROVIDED IN THE CORRECTION LETTER TO OPTIMIZE CALIBRATOR PREPARATION. FOR LOTS GOING FORWARD, UNTIL A PERMANENT SOLUTION IS IDENTIFIED, AN ALERT CARD IS BEING INCLUDED WITH THE PRODUCT TO INSTRUCT THE CUSTOMER TO REFERENCE THE UMDC COMMUNICATION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER OBSERVED INCOMPLETE DISSOLUTION OF MMB CALIBRATOR RC420 LOT 2KD024 WHEN CALIBRATING THE MMB REAGENT. QC WAS FOUND OUT OF RANGE. RESULTS WERE NOT REPORTED WHILE QC WAS OUT OF RANGE. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED DUE TO THE INCOMPLETE CALIBRATOR DISSOLUTION. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE INCOMPLETE CALIBRATOR DISSOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274013 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM MASS CREATINE KINASE MB ISOENZYME CALIBRATOR JIT SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 2KD024

    Patients

    Seq Age Sex Outcome Treatment
    1