BEUDAMED
    FDA Adverse Event Summary report: N

    DAKO OMNIS

    MDR report key: 5581967 · Received April 15, 2016

    Report

    Report Number
    9610099-2016-00003
    Date Received
    April 15, 2016
    Date of Event
    March 17, 2016
    Report Date
    April 3, 2017
    Manufacturer
    DAKO DENMARK A/S
    Product Code
    KPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL FOLLOW-UP INFORMATION: ROOT CAUSE: THE ROOT CAUSE FOR THE STAINING INCONSISTENCY IS INSUFFICIENT PRIMARY ANTIBODY DISPENSED TO THE SLIDE DUE TO A DOUBLE FAILURE: · LIQUID LEVEL DETECTION ABOVE ACTUAL LIQUID SURFACE CAUSED BY FOAM IN VIAL AT FIRST USE. · FAILURE OF THE MITIGATION BUILT INTO THE SOFTWARE AS THE ACTUAL LIQUID LEVEL WAS LOWER THAN THE EXPECTED LEVEL. THIS WAS MOST LIKELY CAUSED BY DROPLETS LINING THE INSIDE OF THE VIAL ABOVE THE LIQUID. CORRECTIVE ACTIONS TAKEN AS RESULT OF THE INVESTIGATION. (B)(4) RAISED TO SOLVE THE INCIDENT. SHORT SUMMARY: THE OMNIS INSTRUMENT SOFTWARE HAS BEEN UPDATED TO INCREASE THE EXISTING SUBMERSION OF THE PROBE INTO THE REAGENT BEFORE ASPIRATION FROM 2 MM TO 8 MM. THUS, THE TIP GOES 6 MM FURTHER INTO THE LIQUID BEFORE STARTING TO ASPIRATE. IN THE DAKO OMNIS LARGE VIAL, USED IN BOTH THESE INCIDENTS, THE 6 MM CORRESPONDS TO A VOLUME OF APPROXIMATELY 2.5 ML, WHICH IS TOO LARGE A VOLUME TO GET CAUGHT AS DROPLETS ON THE INSIDE OF THE VIAL. THIS CHANGE HAS BEEN CONFIRMED IN A VERIFICATION TEST TO MITIGATE THE RISK OF THE INCIDENT. THE UPDATED SOFTWARE WAS RELEASED ON 18-NOV-2016. THE OMNIS INSTRUMENT SOFTWARE VERSION 2.1.1 CONTAINING THIS CHANGE HAS BEEN IMPLEMENTED AT (B)(6) ON 18-JAN-2017, AND IT WILL BE MONITORED AS PART OF CAPA (B)(4) THAT NO FURTHER INCIDENTS OF THIS TYPE OCCUR.

    Description of Event or Problem · 1

    CALGARY LAB SERVICES, (B)(4), COMPLAINED ABOUT FALSE NEGATIVE STAINING WITH AN ANTIBODY AGAINST WILMS' TUMOR 1 (WT1) PROTEIN ON THE DAKO OMNIS INSTRUMENT. THE FALSE NEGATIVE STAINING WAS ONLY SEEN ON THE CONTROL SLIDE. DAKO DOES NOT MARKET A WT1 READY-TO-USE ANTIBODY FOR THE DAKO OMNIS AND THE WT1 ANTIBODY IS THEREFORE NOT VALIDATED FOR THE DAKO OMNIS. DAKO IS IN THE PROCESS OF OBTAINING THE INSTRUMENT LOG FILES FROM THE CUSTOMER IN ORDER TO DETERMINE AND INVESTIGATE THE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235939 DAKO OMNIS DAKO OMNIS KPA DAKO DENMARK A/S GI100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other