MAUDE Adverse Event Report: BECKMAN COULTER DXI 800 ACCESS IMMASSY W/SPOT B; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number DXI 800 ACCESS IMMASSY W/SPOT B

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Laceration(s) (1946)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

Operator was injured while performing routine troubleshooting.The operator reported visiting the hospital nurse with a cut on his arm.The operator was on blood thinners.No further information is available regarding prescribed treatment or medication.Based on the information provided by the operator, it was determined that the operator failed to follow instructions for use (ifu) regarding touching the instrument while in use.Per power processor generic/idc and dxi connection modules ifu (instruction for use), document id (b)(4), moving parts label indicates moving parts that can pinch or crush.¿this label is found in several locations.Caution parts move automatically.While the system is in operation, do not touch or go close to any moving parts.Close protective guards and covers during operation.Failure to close covers correctly can cause injury or incorrect results.¿ a beckman coulter field service engineer (fse) was dispatched to the customer site.The fse reported no hardware errors.The fse also reported the sample pipettor gantry cover does not shut on its own if fully open.The fse reported that the door would close if bumped.The failure mode was confirmed to be use error.Beckman coulter internal identifier: case-(b)(4).

Event Description

On (b)(6) 2019 the customer reported an injury to an operator's arm due to use error.While the operator was troubleshooting, the dxi rear pipettor sample gantry cover fell on the operator's arm and caused his arm to bleed.The operator was seen by the hospital nurse for treatment consisting of bandaging the injury.The customer further stated that the cut was made worse due to the fact that the operator was taking blood thinners (blood thinner medication not specified).No further information regarding treatment or outcome was provided.

• Brand Name: DXI 800 ACCESS IMMASSY W/SPOT B
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 8976770
• MDR Text Key: 161308827
• Report Number: 2122870-2019-01118
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 15099590369194
• UDI-Public: (01)15099590369194(11)110803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DXI 800 ACCESS IMMASSY W/SPOT B
• Device Catalogue Number: A71456
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/22/2019
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other