BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK 2 XL BLUE MODULE COLORIMETERIC

    MDR report key: 5876559 · Received August 15, 2016

    Report

    Report Number
    1950204-2016-00095
    Event Type
    Injury
    Date Received
    August 15, 2016
    Date of Event
    July 16, 2016
    Report Date
    February 14, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    N50510 S082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED ON THE UNIT'S PIPETTER SYSTEM ASSEMBLY WHICH WAS RETURNED TO BIOMÉRIEUX. THE BIOMÉRIEUX INSTRUMENT REPAIR CENTER (IRC) PERFORMED AN INVESTIGATION. THE IRC TECHNICIAN REMOVED AND REPLACED THE DRUM HOUSING THIRTY (30) TIMES WITHOUT DIFFICULTY. THE PIPETTE SYSTEM ASSEMBLY PASSED ALL THE IRC TESTING. QUALITY CONTROL MEASURED THE RETURNED DRUM HOUSING AND MOUNTING BLOCK OF THE PIPETTER SYSTEM ASSEMBLY AND ALL MEASUREMENTS WERE WITHIN SPECIFICATIONS. ENGINEERING PERFORMED A VISUAL INSPECTION OF THE RETURNED PIPETTER SYSTEM ASSEMBLY INCLUDING THE DRUM HOUSING AND MOUNTING BLOCK, AND FOUND NO VISIBLE DAMAGE. ENGINEERING REMOVED AND INSTALLED THE DRUM HOUSING SEVERAL TIMES. WHEN THE DRUM HOUSING IS AT 90 DEGREES, IT IS REMOVED EASILY IF PULLED STRAIGHT UP, AND IF PULLED OUT AT AN ANGLE IT TAKES GREATER FORCE TO REMOVE IT. THE DRUM HOUSING ROTATES TO 0 DEGREES FOR OPERATION WHEN IT IS SEATED FIRMLY AND ALIGNED PROPERLY IN THE MOUNTING BLOCK. IF THE DRUM WAS NOT IN THE MOUNTING BLOCK CORRECTLY IT WOULD NOT ROTATE TO 0 DEGREES FOR OPERATION AND WOULD BECOME STUCK AT AN ANGLE. SIX (6) QUALIFIED EMPLOYEES WERE ABLE TO REMOVE THE DRUM HOUSING WITHOUT ANY ISSUE. ENGINEERING REVIEWED THE VITEK® 2 USER MANUAL INSTRUCTIONS TO INSTALL THE PIPETTE TIPS. THE USER MANUAL INSTRUCTS THE USER TO MAKE SURE THAT THE DRUM HOUSING IS FIRMLY SEATED AND THE KEY PIN ON ITS SIDE MUST MATE WITH THE SLOT ON THE DRUM MOUNTING BLOCK. THERE IS A NOTE STATING THAT IF DRUM HOUSING IS NOT SEATED CORRECTLY, THE USER WILL NOT BE ABLE TO ROTATE IT BACK INTO POSITION. IT WAS REPORTED, THE INSTRUMENT (S/N VTK2XL2177) WAS AT ROOM TEMPERATURE (74 DEGREES F) AND WAS NOT EXPOSED TO EXTREME TEMPERATURES BEFORE THE INCIDENT. THE DEVICE HISTORY RECORD (DHR) FOR S/N VTK2XL2177 WAS REVIEWED. THE INSTRUMENT PASSED ALL TESTING. CONCLUSION: THIS INVESTIGATION DEMONSTRATED THAT THE RETURNED PIPETTE SYSTEM ASSEMBLY IS WORKING PROPERLY. THIS INVESTIGATION ALSO VERIFIED THAT THE RETURNED DRUM HOUSING AND DRUM MOUNTING BLOCK ARE TO SPECIFICATION AND ARE NOT DAMAGED. ENGINEERING WAS ONLY ABLE TO REPRODUCE THE CONDITION OF THE DRUM HOUSING STUCK AT AN ANGLE WHEN THE DRUM HOUSING WAS NOT SEATED FIRMLY AND ALIGNED PROPERLY WITH THE DRUM MOUNTING BLOCK, PER THE USER MANUAL'S INSTRUCTIONS. POTENTIALLY, COLDER TEMPERATURES MAY HAVE REDUCED THE SIZE OF THE HOLE ON THE DRUM MOUNTING BLOCK, CAUSING A POTENTIAL TIGHTER FIT WITH THE DRUM HOUSING . HOWEVER, THE INSTRUMENT WAS AT ROOM TEMPERATURE, AND IT IS NOT LIKELY THAT THE DRUM MOUNTING BLOCK WAS SUBJECTED TO COLDER TEMPERATURES WITH THE INSTRUMENT INCUBATOR TEMPERATURE HOTTER (35.5 DEGREES C +/- 1 DEGREE C). THE INVESTIGATION CONCLUDED THAT THE PROCEDURE FOR INSTALLING THE PIPETTE TIPS WAS NOT FOLLOWED PER THE USER MANUAL INSTRUCTIONS. THE USER SHOULD MAKE SURE THAT THE DRUM HOUSING IS FIRMLY SEATED AND THE KEY PIN ON ITS SIDE, MUST MATE WITH THE SLOT ON THE DRUM MOUNTING BLOCK. THERE IS A NOTE STATING THAT IF DRUM HOUSING IS NOT SEATED CORRECTLY, THE USER WILL NOT BE ABLE TO ROTATE IT BACK INTO POSITION.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMERIEUX TO REPORT AN INJURY TO A USER WHILE ATTEMPTING TO REMOVE THE PIPETTE TIP DRUM FROM THE VITEK 2 XL INSTRUMENT. AFTER PREVIOUSLY REMOVING THE DRUM, REFILLING IT WITH PIPETTES AND REPLACING THE DRUM, THE DRUM GOT STUCK IN THE HOLDER AT AN ANGLE. THE USER PULLED AGGRESSIVELY ON THE DRUM, AND WHEN THE DRUM BROKE FREE IT HIT THE USER'S FOREHEAD. THE USER SUSTAINED A ONE-HALF INCH LACERATION ON HER FOREHEAD. SHE WENT TO THE EMERGENCY ROOM (ER) FOR TREATMENT; THE ER STAFF APPLIED GLUE TO CLOSE THE WOUND (NO STITCHES WERE USED), PRESCRIBED PAIN MEDICATION AND SENT THE EMPLOYEE HOME FOR TWO DAYS. UPON RETURN TO WORK, HER SUPERVISOR STATED SHE WAS "FOGGY", AND SENT HER TO THE ER, WHICH PERFORMED A CAT SCAN. THE EMPLOYEE WAS SENT HOME ON WORKMAN'S COMPENSATION, AND WAS REFERRED TO NEUROLOGY. THE LOCAL FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO INSPECT THE INSTRUMENT. THE FSE IDENTIFIED NO PROBLEM WITH THE INSTRUMENT. THE DRUM SLIPPED IN AND OUT EASILY. HE USER DID NOT GET THE DRUM SEATED PROPERLY BEFORE SHE ROTATED IT DOWN AFTER REPLACING THE PIPETTES. WHEN SHE ROTATED IT DOWN, SHE HIT THE SIDE COVER WHICH JAMMED THE ROTOR INTO ITS HOLDER AT AN ANGLE CAUSING IT TO STICK. SHE THEN STOOD ON A STOOL TO GET ABOVE THE DRUM AND ATTEMPTED TO PULL IT UP. WHEN IT CAME LOOSE THE MOMENTUM OF HER PULLING AGGRESSIVELY CAUSED THE DRUM TO STRIKE HER IN THE HEAD. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527551 VITEK 2 XL BLUE MODULE COLORIMETERIC VITEK 2 XL LON BIOMERIEUX, INC 27227

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention