BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSTRUMENT MANAGER

    MDR report key: 6069088 · Received October 28, 2016

    Report

    Report Number
    MW5065730
    Event Type
    Other
    Date Received
    October 28, 2016
    Date of Event
    August 1, 2015
    Report Date
    October 27, 2016
    Manufacturer
    DATA INNOVATIONS
    Product Code
    JQP
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON SEPTEMBER 29, 2016 DATA INNOVATION WAS NOTIFIED BY ABBOTT DIAGNOSTICS THAT ONE OF THEIR CUSTOMER ((B)(6)) SENT THEM A COMPLAINT FOR A POTENTIAL REPORTABLE EVENT ((B)(4)) BECAUSE RESULTS THAT SHOULD BE REPORTED AS (B)(6) WERE REPORTED AS (B)(6) ON (B)(6) 2016. A SPECIMEN IS RUN AND RESULT IS (B)(6) CAUSING DUPLICATE TESTS TO BE ORDERED. A RULE WAS WRITTEN TO PROCESS THE DUPLICATE TESTS, HOWEVER, THE RULE FIRES PREMATURELY BECAUSE THERE IS NO TEST CODE IN THE SEL EVENT AND THE RESULTS ARE EVALUATED WITH NO TEST RESULTS. CUSTOMER INDICATED THAT (B)(6) RESULTS ARE BEING REPORTED AS (B)(6) AS A RESULT OF THIS RULE FIRING. THIS WAS DUE TO A USER ERROR OF INSTRUMENT MANAGER. THE RULE WAS WRITTEN INCORRECTLY AND DID NOT CONTAIN 'IS NUMERIC' AND 'TEST RESULTED' AS IT SHOULD HAVE, AND THE VALIDATION PERFORMED BY THE SITE DID NOT DETECT THIS ISSUE. SITE REPORTED THE ISSUE AND INDICATED THEY DISCOVERED IN THE LAB SO THERE NO PT HARM FOR THIS INCIDENT. THE ISSUE IS BEING REPORTED BECAUSE ERRONEOUS RULES HAVE BEEN IN PLACE SINCE AUGUST 2015, SO IT IS POSSIBLE THAT (B)(6) TEST RESULTS SHOULD HAVE BEEN REPORTED AS (B)(6) WERE REPORTED AS (B)(6). DATA INNOVATIONS HAS NOT RECEIVED REPORTS OF HARM BUT REPORTING BECAUSE PTS COULD HAVE POSSIBLY BEEN HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713840 INSTRUMENT MANAGER CALCULATOR/DATA PROCESSING FOR CLINICAL USE JQP DATA INNOVATIONS 8.12.12

    Patients

    Seq Age Sex Outcome Treatment
    1 NA