BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABX MINOTROL 16

    MDR report key: 3185295 · Received June 6, 2013

    Report

    Report Number
    2086725-2013-00010
    Event Type
    Other
    Date Received
    June 6, 2013
    Report Date
    May 10, 2013
    Manufacturer
    HORIBA MEDICAL
    Product Code
    GKZ
    PMA / PMN Number
    K843962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE STATEMENT WAS VESTIGIAL VERBIAGE LEFT OVER FROM A TIME WHEN THE SOFTWARE ON THE MICRO 60 DID NOT HAVE A SPECIFIC QC MODE AND THE DIFFERENTIAL FLAGS GENERATED WHEN THE QC WAS RUN CONFUSED SOME CUSTOMERS. NOW THAT THE SOFTWARE HAS BEEN UPDATED TO INCLUDE A QC MODE, THIS STATEMENT IS NO LONGER NEEDED AND WILL BE REMOVED IN FUTURE MINOTROL (B)(4) LOTS TO AVOID FUTURE CUSTOMER CONFUSION. THE USER MANUAL FOR THE ABX MICROS 60 CLEARLY STATES IN SECTION 1.2.6.2.: "ERROR FLAGS SUCH AS (H, L, *, S, !, FOR HGB) ON CONTROL RESULTS ARE NON-VALID RESULTS). THE PARAMETERS WITH THESE SPECIFIC FLAGS SHOULD BE REVIEWED AND QUESTIONED BEFORE CONTINUING WITH THE NEXT LEVEL OF CONTROL BLOOD." ADD'L CAT # FOR MX053: C01A2043748, C01A2043752, C01A2043756. PMA510(K) #: K843962 K850755.

    Description of Event or Problem · 1

    CLIA INSPECTOR REPORTED TO HORIBA MEDICAL (HORIBA) THAT THE MINOTROL 16 INSERT SHEET (B)(4), STATED "WHEN RUNNING A CONTROL OR A CALIBRATOR, THE INSTRUMENT FLAGS MAY BE IGNORED" AND THAT THE CUSTOMER WAS LITERALLY IGNORING ALL OF THE INSTRUMENT FLAGS. THE CLIA INSPECTOR WAS ON SITE AND HAD QUESTIONS ON THE QC MX072 RUN BY THE CUSTOMER. THE CUSTOMER HAD SUBMITTED QC RESULTS FROM MX072 WITH HIGH (H) AND LOW (L) FLAGS. THE CUSTOMER MAY HAVE MISUNDERSTOOD THAT THE H AND L FLAGS ARE IMPORTANT AND INDICATE THAT THE QC PARAMETER RESULT IS OUTSIDE OF THE ASSAY RANGE AND NOT TO BE IGNORED. THE CLIA INSPECTOR WAS ADVISED THAT THE HIGH (H) AND LOW (L) FLAGS ARE IMPORTANT AND TO HAVE CUSTOMER CHECK THE RESULTS AGAINST THE QC ASSAY SHEET. THIS IS A LABELING MALFUNCTION ISSUE. A CORRECTIVE ACTION IS BEING TAKEN TO REMOVE THE FOOTNOTE FROM THE ASSAY SHEET TO HELP AVOID ANY FUTURE CONFUSION BY END USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251879 ABX MINOTROL 16 MINOTROL 16 GKZ HORIBA MEDICAL MX072

    Patients

    Seq Age Sex Outcome Treatment
    1