BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMISOL ADVANCE

    MDR report key: 7949512 · Received October 9, 2018

    Report

    Report Number
    3006543086-2018-01000
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    June 29, 2018
    Report Date
    September 10, 2018
    Manufacturer
    NORMAND-INFO S.A.S.U.
    Product Code
    JQP
    UDI-DI
    13700962600938
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NORMAND TECHNICAL SUPPORT AND AN INFORMATICS TECHNICAL SPECIALIST REVIEWED THE ISSUE, AND OBSERVED THE AUTO-VALIDATION STOPPING COMMENT LINKED TO FERRITIN WAS REMOVED WHEN THE RESULT WAS DELETED. THEN WHEN THE SAMPLE WAS RERUN, THIS COMMENT WAS NOT RECREATED BECAUSE THE RULE THAT GENERATED IT WAS CONFIGURED TO PLAY ONCE. THIS LED TO THE FERRITIN RESULT BEING AUTO-VALIDATED AS THE AUTO-VALIDATION RULE WAS UNABLE TO FIND THE MISSING COMMENT. THE CAUSE OF THE ISSUE IS ATTRIBUTED TO USE ERROR DUE TO AN INCORRECT RULE AND THE CUSTOMER DELETING A RESULT. THE ISSUE WAS RESOLVED BY MODIFYING THE RULE IN REMISOL AND DISCUSSING THE CORRECT MANAGEMENT OF THE FAILURE AND RESULTS WITH THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEIR REMISOL AUTO-VALIDATED AN ERRONEOUS PATIENT RESULT FOR FERRITIN. THE ERRONEOUS RESULT WAS AUTO-RELEASED OUT OF THE LABORATORY. THE PHYSICIAN STOPPED TREATMENT FOR A PATIENT BASED ON THE ERRONEOUS RESULT. PATIENT TREATMENT WAS RESUMED UPON NOTIFICATION OF THE ISSUE. NO SPECIFIC DETAILS OF THE PATIENT TREATMENT WERE PROVIDED. THERE WAS NO REPORT OF HARM TO THE PATIENT. NO DETAILS WERE PROVIDED IN REGARDS TO THE INSTRUMENT USED TO RUN THE PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786952 REMISOL ADVANCE REMISOL ADVANCE JQP NORMAND-INFO S.A.S.U. NA NA 13700962600938

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other