BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 IMMUNOCHEMISTRY ANALYZER

    MDR report key: 834368 · Received March 16, 2007

    Report

    Report Number
    1823260-2007-02133
    Event Type
    Malfunction
    Date Received
    March 16, 2007
    Date of Event
    February 11, 2007
    Report Date
    March 16, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED COMPLAINTS FROM PHYSICIANS REGARDING LOW RECOVERY OF B12 ON ELECSYS 2010 WHEN COMPARING THE RESULT TO B12 MEASURED ON THE MODULAR ANALYTICS E170 SYSTEM. THE RECOVERY ON ELECSYS 2010 IS LOWER FOR PT SAMPLES. EIGHT PT SAMPLE RESULTS PROVIDED AS FOLLOWS: PT 1 2010 B12 <22 PMOL/L, E170 89.86 PMOL/L. PT 2 2010 B12 <22.4 PMOL/L, E170 69.25 PMOL/L. PT 3 2010 B12 16.27 PMOL/L, E170 267.5 PMOL/L. PT 4 2010 B12 118.5 PMOL/L, E170 254.3 PMOL/L. PT 5 2010 B12 85.12 PMOL/L, E170 138.5 PMOL/L. PT 6 2010 B12 43.66 PMOL/L, E170 152.8 PMOL/L. PT 7 2010 B12 87.31 PMOL/L, E170 214.4 PMOL/L. PT 8 2010 B12 <22 PMOL/L, E170 99.43 PMOL/L. IF ADDITIONAL INFO IS REC'D, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 IMMUNOCHEMISTRY ANALYZER ELECSYS 2010 - JJE JJE ROCHE DIAGNOSTICS 2010 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA