MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number UNICEL DXH SLIDEMAKER STAINER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/13/2023

Event Type  Injury  

Event Description

The bec employee (field service engineer, fse) reported that while troubleshooting on dxh sms, he suffered a lower back injury when reinstalling the dxh sms sample transport module (stm).The fse stated he immediately notified his manager and called the employee nurse hotline.The hotline scheduled a doctor's appointment for next day on ((b)(6) 2023).The fse stated he was administered a toradol injection and prescribed methyl prednisolone, and the doctor requested an mri to evaluate the severity of the condition.The fse was out for two weeks on workman's compensation.

Manufacturer Narrative

In a follow up communication, the fse stated his condition has been improving and there has been no complications since initial incident.The injury was not a result of a malfunction.The event occurred as a result of user error, the fse should not have attempted to lift the heavy part by himself.Per service manual pn 4237476 current rev, section 3.19 [installation on bench top] moving spm, unpacking shipping crate, and checking accessory kit.Risk of operator injury, lower back, or pinch injury.The weight of the spm with the stm module removed is 77 kg (170 lbs.).Exercise caution and follow all published ehs guidelines.To prevent injury, the lifting handles must be installed, and a minimum of two people are required to safely lift the analyzer.Bec internal identifier: (b)(4).

Manufacturer Narrative

Follow up 01: -section d4 catalog number - corrected to reflect instrument number.Original report reflected component part number from the instrument.-section h4 device manufacture date - updated to reflect correct manufacturing date.

• Brand Name: UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd; brea, CA 92821 ; 7149613625
• MDR Report Key: 17908912
• MDR Text Key: 325336577
• Report Number: 1061932-2023-00107
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590192679
• UDI-Public: (01)15099590192679(11)170421
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNICEL DXH SLIDEMAKER STAINER
• Device Catalogue Number: 775222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other