MAUDE Adverse Event Report: BECKMAN COULTER BIOMEDICAL GMBH DXA 5000; RADIOASSAY, VITAMIN B12

Model Number ASSY MAIN STRAIGHT 1250MM DTS DXI - TRAN

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 01/26/2022

Event Type  Injury  

Manufacturer Narrative

A beckman coulter field service engineer evaluated the dxa track segment and observed a sharp steel sheet on the track segment which caused the injury.The steel sheet is supplied by "(b)(4)".A scar (supplier corrective action request) was initiated to deburr the edges.At the customer site, the installation of the dxa was completed with the cover installed so that the sharp edges cannot be touched.(b)(6).(b)(4).Device manufacture date is unknown.The beckman coulter internal identifier is (b)(4).

Event Description

A beckman coulter fse (field service engineer) reported a cut injury received during the installation of a dxa 5000 track segment.The fse had the muscle tendons of the thumb of his left hand cut, the short extensor tendon was cut, and the long extensor tendon was partially cut.The fse received a tendon anastomosis operation for the cut muscle tendons in the hospital and received prescription medication.It was confirmed that the injury is non-permanent.The fse is expected to be out of work for one and a half months due to this incident.

Manufacturer Narrative

A beckman coulter field service engineer evaluated the dxa track segment and observed the actions performed.It was observed that the fse was performing a torque motion below the track segment where that injury was received, when the motion should have been performed on the outside area of the track segment.It was confirmed that the fse will not return to work for one and a half months.No further treatment or harm was reported.The cause of the injury is attributed to use error.Note: beckman coulter was made aware of the medical intervention on 08-feb-2022.Section a2, a4, and a5: information not provided by customer.Section e1, initial reporter telephone number is (b)(6).Section g1, telephone number is (b)(6).Section h4, device manufacture date is unknown.The beckman coulter internal identifier is (b)(4).

• Brand Name: DXA 5000
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER BIOMEDICAL GMBH; sauerbruchstr. 50; münchen 81377 ; GM 81377
• Manufacturer (Section G): BECKMAN COULTER BIOMEDICAL GMBH; sauerbruchstr. 50; münchen 81377 ; GM 81377
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821
• MDR Report Key: 13596084
• MDR Text Key: 290062880
• Report Number: 3006655511-2022-00001
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590720179
• UDI-Public: (01)15099590720179(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K190298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASSY MAIN STRAIGHT 1250MM DTS DXI - TRAN
• Device Catalogue Number: B77037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention