BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNA PURE LC 2.0

    MDR report key: 1871282 · Received October 15, 2010

    Report

    Report Number
    1823260-2010-06159
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 27, 2010
    Report Date
    November 24, 2010
    Product Code
    LXG
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1823260-10/25/2010-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. FURTHER INVESTIGATION HAS DETERMINED. DATE OF EVENT SHOULD BE (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT SHOULD BE (B)(6) 2010. INTERNAL INVESTIGATIONS REVEALED THE EXISTENCE OF TWO SOFTWARE ISSUES WITH THE MAGNA PURE LC 2.0 INSTRUMENT SOFTWARE 1.1 (ALL VERSIONS) REGARDING THE INCORRECT PRINTING OF BARCODES, WHICH CAN LEAD TO SAMPLE MISIDENTIFICATION. EACH TIME A BARCODE IS PRINTED FROM THE BATCH RESULTS SCREEN, A WRONG BATCH ID WILL BE PRINTED, WHILE THE CORRECT BATCH ID IS ASSIGNED TO THE BATCH IN THE DATA REPOSITORY OF THE MAGNA PURE LC 2.0 SOFTWARE. THIS MAY RESULT IN SAMPLE MISIDENTIFICATION. EACH TIME THE BARCODE FOR THE COOLING BLOCK IS PRINTED FROM THE POST ELUTION RESULT SCREEN, A WRONG BATCH ID FOR THE COOLING BLOCK WILL BE PRINTED IF: - ANOTHER PURIFICATION WAS RUN WITHOUT A SUBSEQUENT POST ELUTION RUN, OR - AN OLD BATCH IS LOADED FROM THE BATCH RESULTS OR THE POST ELUTION EDIT SCREEN. THE CORRECT BATCH ID WILL BE ASSIGNED TO THE BATCH IN THE DATA REPOSITORY OF THE SOFTWARE. THIS MAY RESULT IN SAMPLE MISIDENTIFICATION. THE AFFECTED ROCHE IVD TESTS ARE: - FACTOR V LEIDEN KIT FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT - FACTOR II (PROTHROMBIN) (B)(4) KIT FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT IF EITHER OF THESE ISSUES WERE TO OCCUR, IT COULD POSSIBLY LEAD TO THE MISIDENTIFICATION OF SAMPLES AND, ULTIMATELY, TO THE REPORTING OF ERRONEOUS BUT BELIEVABLE RESULTS, INCLUDING FALSE POSITIVE AND FALSE NEGATIVE RESULTS. PATIENTS WITH FALSE POSITIVE RESULTS FOR FACTOR V LEIDEN OR FACTOR II (PROTHROMBIN) MUTATIONS COULD ERRONEOUSLY BE ASSIGNED TO LONG TERM ANTICOAGULATION AND SUFFER SERIOUS OR LIFE THREATENING BLEEDING FROM THAT TREATMENT. PATIENTS WITH FALSE NEGATIVE RESULTS FOR FACTOR V LEIDEN OR FACTOR II (PROTHROMBIN) MUTATIONS COULD BE ERRONEOUSLY DENIED LONG TERM ANTICOAGULATION AND SUFFER SERIOUS OR LIFE THREATENING BLOOD CLOTS. AN URGENT MEDICAL DEVICE CORRECTION NOTICE WAS MAILED (B)(6) 2010 TO CUSTOMERS WITH WORKAROUNDS FOR THESE ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED A PROBLEM WITH THE MAGNA PURE LC 2.0'S ABILITY TO PRINT THE CORRECT BATCH ID BARCODE FROM THE BATCH RESULTS SCREEN. THE MAGNA PURE'S PRINT BAR CODE - BATCH ID FUNCTIONALITY MAY BE ACCESSED FROM THREE DIFFERENT SCREENS: 1. THE ORDERING SCREEN, 2. THE STAGE SETUP SCREEN, AND 3. THE BATCH RESULTS SCREEN. PRELIMINARY INVESTIGATION REVEALED THAT WHEN A BATCH ID BARCODE LABEL IS REQUESTED FROM THE BATCH RESULTS SCREEN THE INSTRUMENT PRINTS THE BARCODE FOR THE BATCH ID THAT IS CURRENTLY ASSIGNED IN THE ORDERING SCREEN, RESULTING IN A POSSIBLE SAMPLE MISMATCH. THERE WAS NO ALLEGATION OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNA PURE LC 2.0 EQUIPMENT, LABORATORY, GENERAL PURPOSE LXG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1