BEUDAMED
    FDA Adverse Event Other Summary report: N

    WATERS QUATTRO MICRO

    MDR report key: 2222864 · Received August 10, 2011

    Report

    Report Number
    9616673-2011-00003
    Event Type
    Other
    Date Received
    August 10, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 9, 2011
    Manufacturer
    WATERS CORP.
    Product Code
    DOP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE EVENT BY WATERS' TECHNICAL SUPPORT AND THE CUSTOMER DETERMINED THAT THE INCORRECT RESULTS WERE CAUSED BY ALTERATIONS MADE TO THE SAMPLE LIST DURING THE RUN OF IMMUNOSUPPRESSANT SAMPLE SET USING MASSLYNX SOFTWARE. THE CUSTOMER REQUESTED AND RECEIVED CLARIFICATION FROM WATERS ON HOW TO CORRECTLY ALTER A SAMPLE LIST DURING THE RUN. FURTHER REVIEW OF THE ISSUE BY A WATERS (B)(4) AND A WATERS (B)(4) DETERMINED THAT THE MASSLYNX SOFTWARE OPERATED AS DESIGNED. APPROPRIATE F/U ACTION WILL BE TAKEN IF REQUIRED. IF ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE RUNNING IMMUNOSUPPRESSANT ASSAYS ON A MASS SPECTROMETER, THEY ENTERED A SAMPLE LIST FILE THAT HAD ERRORS. AFTER THE RUN WAS STARTED, THE CUSTOMER CORRECTED THE ERRORS ON THE SAMPLE LIST, BUT DID NOT RESTART THE BATCH RUN AS REQUIRED. SUBSEQUENTLY, INCORRECT RESULTS WERE REPORTED TO PHYSICIANS. AS REPORTED BY THE CUSTOMER, ONE PHYSICIAN CONTACTED THE LAB AND QUESTIONED THE RESULTS. THIS PHYSICIAN DID NOT USE THE RESULTS FOR DIAGNOSTIC PURPOSES. THE CUSTOMER RE-RAN ALL THE SAMPLES TESTED IN THE SUSPECT BATCH, AND SUBMITTED CORRECTED RESULTS TO ALL AFFECTED PHYSICIANS WITHIN THREE OR FOUR HRS AFTER THE INCORRECT RESULTS WERE REPORTED. THE CUSTOMER HAS NOT RECEIVED ANY REPORTS OF ADVERSE PT HEALTH CONSEQUENCES AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WATERS QUATTRO MICRO MASS SPECTROMETER FOR CLINICAL USE (DOP) DOP WATERS CORP. QUATTRO MICRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1