BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHD SYSTEM

    MDR report key: 1993367 · Received February 8, 2011

    Report

    Report Number
    2915274-2011-00001
    Event Type
    Other
    Date Received
    February 8, 2011
    Date of Event
    January 10, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    JTC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG# 426-0246. A MEDICAL DEVICE CORRECTION ADVISORY NOTICE WAS SENT TO ALL PHD CONSIGNEES ADVISING THEM TO ENSURE THAT QUANTITATIVE RESULTS HAVE PASSED ALL VALIDATION CRITERIA (QUALITATIVE RESULTS), BY LOOKING AT THE PHD WORKLIST RESULTS PRIOR TO REPORTING PT RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER WHO CONFIGURED HER LABORATORY INFORMATION SYSTEM (LIS) NOT TO PROCESS QUALITATIVE RESULT MESSAGES (E.G."INVALID"), RAN A VITAMIN D ASSAY, WHERE THE NEGATIVE CONTROL FAILED. BOTH QUALITATIVE ("INVALID") AND QUANTITATIVE (NUMERICAL) RESULTS WERE REPORTED ON THE PHD DEVICE WORKLIST RESULTS. IN THIS CASE, THE "INVALID" MESSAGE ASSOCIATED WITH THE VITAMIN D TEST, WHICH FAILED A PROGRAMMED VALIDATION RULE, SHOWED-UP ONLY ON THE PHD WORKLIST RESULTS, BUT NOT ON THE LIS OUTPUT FILE. THIS COULD PRESENT A RISK FOR PT MISDIAGNOSIS OR MISTREATMENT, IF A HEALTHCARE PROVIDER ONLY SEES THE QUANTITATIVE RESULTS FROM THE LIS AND DOES NOT SEE THE QUALITATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHD SYSTEM STATION, PIPETTING & DILUTING, CLINIC USE JTC BIO-RAD LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1