BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 6922349 · Received October 6, 2017

    Report

    Report Number
    1056600-2017-00085
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    September 9, 2017
    Report Date
    October 6, 2017
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INSTRUMENT HAS BEEN INVESTIGATED. ON 09-14-2017 AN ORTHO FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND PERFORMED HEALTH CHECK PER SERVICE PUBLICATIONS. CLEANED READER CAMERA AREA, HANDLER AND VISOR. ADJUSTED GRIPPER ALIGNMENT AND VERIFIED ALIGNMENT IN WAD DIAGNOSTIC AND TIF IMAGES. UPDATED READER REFERENCE IMAGE AND VERIFIED TIF IMAGE. FE CHECKED CAMERA BRIGHTNESS (ACCEPTABLE RANGE IS 101 TO 128) PROVUE WAS FOUND TO BE WITHIN RANGE AT 119. THE ROOT-CAUSE COULD NOT BE CONFIRMED ALTHOUGH THE MOST PROBABLE ROOT CAUSE IS ASSOCIATED WITH AN ANTI-LEB BEING WEAK AND/OR AT THE DETECTION LIMIT OF THE TECHNIQUE AND REAGENTS USED. ALTHOUGH PATIENT WAS TRANSFUSED LEB POSITIVE UNIT, NO TRANSFUSION REACTION OR HARM TO PATIENT WHEN INCIDENT WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS ONE EVENT OF A FALSE NEGATIVE ANTIBODY SCREEN RESULT FOR A PATIENT SAMPLE THAT WAS TESTED ON (B)(6) 2017. FURTHER TESTING ON (B)(6) 2017 DETERMINED THE PATIENT HAD ANTI-LEB AND THE ANTIBODY SCREEN SHOULD HAVE BEEN POSITIVE. AN ELECTRONIC CROSSMATCH WAS DONE ON (B)(6) 2017 AND THE UNIT THAT WAS TRANSFUSED ANTIGEN TYPED LEB POSITIVE. THIS LED THE CUSTOMER TO PERFORM A TRANSFUSION REACTION WORKUP AS A PRECAUTION, THOUGH THE PATIENT DID NOT HAVE ANY SYMPTOMS. ALL RESULTS INDICATED THERE WAS NO TRANSFUSION REACTION TO DATE. MOVING FORWARD, THE CUSTOMER HAS NOTED THIS PATIENT HAS THE ANTIBODY AND REQUIRES FULL CROSSMATCHES AS PER THEIR POLICY. CUSTOMER ELABORATED ON HOW THE RETEST OF THE SAMPLE OCCURRED ON (B)(6) 2017. THIS SAMPLE WAS ARBITRARILY CHOSEN TO BE RUN ON THEIR OTHER PROVUE FOR PARALLEL TESTING. THEIR OTHER PROVUE, SERIAL (B)(4) GAVE A 1+ REACTION WITH THIS SAME EDTA SAMPLE WITH VSS929 CELL 2. IT WAS BARCODED AS "TEST". THIS DISCREPANCY BETWEEN RESULTS BETWEEN THE TWO PROVUES TRIGGERED ADDITIONAL REPEAT TESTING TO BE DONE BY MANUAL GEL METHOD. IT WAS AGAIN CONFIRMED THAT CELL#2 WAS 1+ POSITIVE WITH THE PATIENT SAMPLE. THE ANTIBODY ID WAS DONE AND ANTI-LEB WAS IDENTIFIED. THE LOT NUMBERS IN USE WERE: IGG GEL CARD LOT 040517001-15 EXP 3/7/2018 AND 0.8% SURGISCREEN LOT VSS929 EXP 9/12/2017 (TESTED PRIOR TO EXPIRATION). EACH TESTING EVENT WAS DONE WITH DIFFERENT SETS OF CELLS, BUT THE SAME LOT VSS929. ALL REAGENTS USED HAVE PASSED QC/VISUAL INSPECTIONS AND WERE STORED AS PER MANUFACTURER'S RECOMMENDATIONS. NO ISSUES WITH DELIVERY AND HANDLING OF THE PRODUCTS HAVE BEEN RECORDED AT THIS SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705530 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1