BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVI® COLOR GRAM V2

    MDR report key: 5903288 · Received August 25, 2016

    Report

    Report Number
    3002769706-2016-00153
    Event Type
    Injury
    Date Received
    August 25, 2016
    Report Date
    August 2, 2016
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    KPA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A DISCREPANT GRAM STAIN RESULT (GRAM POSITIVE COCCI INSTEAD OF GRAM NEGATIVE ROD) IN ASSOCIATION WITH THE PREVI COLOR V2 INSTRUMENT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. ON (B)(6) 2016, THE CUSTOMER REPORTED A STAINING ISSUE WITH HIS PREVI® COLOR GRAM V2 S/N (B)(4) INVOLVING THREE (3) BLOOD CULTURE SAMPLES. TROUBLESHOOTING WAS INITIATED AND SEVERAL POINTS WERE VERIFIED : - CUSTOMER CLEANED INSTRUMENT NOZZLES. - VOLUME TEST, PATTERN AND QC SLIDES WERE GOOD. - CUSTOMER USED FORMALIN FIXATION : INSTRUMENT IS VALIDATED WITH THIS METHOD OF FIXATION. - SETTINGS USED BY THE CUSTOMER FOR BLOOD SPECIMENS WERE: A (SAFRANINE) =3, B (IODINE) =MED, C (CRYSTAL VIOLET) =MED AND FIXATION=OFF. ON 09-AUG-2016, AFTER TROUBLESHOOTING, THE CUSTOMER CAME BACK TO BIOMÉRIEUX TO REPORT THAT THE PROBLEM WAS SOLVED. THE CUSTOMER INDICATED THEY ATTRIBUTED PART OR ALL OF THE PROBLEM TO THE WASTE BACKING UP BECAUSE THE LINE WAS NOT DRAINING ALL THE WAY DOWN. MOREOVER, THEY STATED THAT THEY PREPARED SOME OF SLIDES TOO THICKLY AND THE WASTE STARTED TO BACK UP. THE CUSTOMER STATED THAT AFTER PERFORMING NOZZLE CLEANING, CONFIRMATION OF CORRECT VOLUMES BEING DELIVERED, REROUTING THE WASTE TUBING, AND EMPHASIZING PROPER FORMALIN USAGE, THE GRAM STAINS ARE PERFORMING AS EXPECTED. IN ADDITION, THE CUSTOMER DRILLED A HOLE IN THE BENCH SO THE WASTE LINE CAN DRAIN WELL INTO THE WASTE. MOST PROBABLE ROOT CAUSE: AFTER INSTRUMENT INSTALLATION, THE CONFIGURATION MAY HAVE BEEN CHANGED (MOVEMENT OF THE INSTRUMENT, OF THE WASTE TUBE OR OF THE WASTE). THIS COULD HAVE CAUSED BENDING OF THE TUBE, A PINCH OF THE WASTE TUBE OR AN INCORRECT INSTALLATION OF THE WASTE (HIGHER THAN THE INSTRUMENT). IT IS ALSO POSSIBLE THAT DURING INSTALLATION BY THE BIOMÉRIEUX REPRESENTATIVE, THE INSTRUMENT MAY HAVE NOT BEEN WELL SET UP IN THE LABORATORY; HOWEVER, AS THE ISSUE APPEARED TWO (2) MONTHS AFTER INSTALLATION, IF THE SETUP WAS NOT CONFORM AND THERE WAS AN INCORRECT DRAIN, THE PROBLEM WOULD HAVE ARRIVED SOONER. MOREOVER, THE CUSTOMER STATED THAT THE WASTE HAD NOT BEEN BACKING UP SINCE INSTALLATION. A WARNING MESSAGE IS WRITTEN IN THE USER MANUAL (REFERENCE 514726-1EN1) THAT INDICATES: "KEEP THE WASTE CONTAINER TUBE STRAIGHT AND AS SHORT AS POSSIBLE. THE MAXIMUM LENGTH IS 2 M (79 IN.). THE WASTE CONTAINER TUBE MUST BE POSITIONED AT A LOWER LEVEL THAN THE TABLE. BIOMÉRIEUX RECOMMENDS INSTALLING THE INSTRUMENT AT ONE END OF THE BENCH TOP. ENSURE THE WASTE TUBE DOES NOT HAVE ANY LOOPS OR KINKS, AND IS AS STRAIGHT AND AS SHORT AS POSSIBLE. CUT OFF EXCESS TUBING AS NEEDED". INFORMATION IS ALSO PRESENT IN SERVICE MANUEL (REFERENCE 514746-1 -- [2013-08]) INDICATING TO, "ADJUST THE TUBE LENGTH TO LESS THAN 1.8 M (72 IN.). ENSURE THE WASTE TUBE DOES NOT HAVE ANY LOOPS OR KINKS, AND IS AS STRAIGHT AND AS SHORT AS POSSIBLE".

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMERIEUX TO REPORT A DISCREPANT GRAM STAIN RESULT (GRAM POSITIVE COCCI INSTEAD OF GRAM NEGATIVE ROD) IN ASSOCIATION WITH THE PREVI COLOR V2 INSTRUMENT. THE ISSUE HAS OCCURRED WITH THREE (3) BLOOD CULTURE SAMPLES. DISCREPANT GRAM STAIN RESULTS WERE REPORTED TO THE PHYSICIAN. THE CUSTOMER INDICATED IMPACT TO PATIENT CARE; HOWEVER, NO DETAILS WERE PROVIDED. THE CUSTOMER WAS DIRECTED TO PERFORM CLEANING OF THE PREVI COLOR INSTRUMENT NOZZLES. WHILE CLEANING, THE CUSTOMER NOTICED DEBRIS ON THE SLIDES AND THAT THE WASTE WAS BACKING UP INTO THE BOWL. BIOMERIEUX SUPPORT CONFIRMED THE WASTE TUBING IS ROUTED INCORRECTLY. THE LABORATORY SUPERVISOR STATED THE LABORATORY TECHNICIANS MAY BE USING TOO MUCH FORMALIN TO FIX THE RED BLOOD CELLS; THE RESULTANT SAMPLE IS TOO THICK. THE CUSTOMER STATED THAT AFTER PERFORMING NOZZLE CLEANING, CONFIRMING CORRECT VOLUMES ARE DELIVERED, REROUTING THE WASTE TUBING, AND EMPHASIZING PROPER FORMALIN USAGE THE GRAM STAINS ARE PERFORMING AS EXPECTED. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556013 PREVI® COLOR GRAM V2 PREVI® COLOR GRAM KPA BIOMERIEUX, SA 414292

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention