BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS AU400E

    MDR report key: 1120764 · Received August 15, 2008

    Report

    Report Number
    8010047-2008-00144
    Event Type
    Other
    Date Received
    August 15, 2008
    Date of Event
    July 16, 2008
    Report Date
    August 15, 2008
    Manufacturer
    OLYMPUS CORPORATION
    Product Code
    JJE
    PMA / PMN Number
    K981743
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INDICATED HUMAN ERROR. IT WAS REPORTED THAT THE OPERATOR MANUALLY ENTERED AN INCORRECT CONCENTRATION VALUE OF 0.089 INSTEAD OF 0.689 ON LEVEL 4 CALIBRATOR. THE IFU FOR THE OLYMPUS HBA1C REAGENT STATES "FOLLOWING CALIBRATION, THE RESULTING CURVE SHOULD BE VISUALLY REVIEWED ON THE OLYMPUS ANALYZER FOR ACCEPTABILITY USING THE SOFTWARE OPTIONS- ROUTINE CALIBRATION MONITOR AND CALIBRATION CURVE". NO FURTHER ACTION IS INDICATED UNLESS OTHER SIGNIFICANT INFO IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN QUESTIONED A %A1C RESULT. THE ACCOUNT HAD REPORTED 2.7%. THE REPEAT RESULT WAS 3.4%. WHEN SENDING SAMPLE TO REFERENCE LAB, THE RESULT WAS 6.1%. IT WAS REPORTED THAT THE LAB NOTIFIED APPROX 43 PTS TO BE REDRAWN AND RETESTED. NO FURTHER INFO WAS PROVIDED. NO INFO HAS BEEN RECEIVED TO SUGGEST ANY ILL EFFECTS ASSOCIATED WITH THIS EVENT. THIS EVENT IS BEING FILED IN AN EXCESS OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AU400E AUTOMATED CLINICAL CHEMISTRY ANALYZER JJE OLYMPUS CORPORATION AU400E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other