MAUDE Adverse Event Report: BECKMAN COULTER BIOMEDICAL GMBH DXA-INPUT-OUTPUT-DEC; RADIOASSAY, VITAMIN B12

Model Number DXA-INPUT-OUTPUT-DEC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

When tightening the lock nut to the analyzer feet, fse was injured with laceration on the right wrist.The fse visited the emergency room and received treatment.The fse evaluated the analyzer and found no evidence of a hardware malfunction.Based on the available information suggests this was an accidental injury.Section a2, a4, and a5: information not provided by customer.Beckman coulter internal identifier is case (b)(4).

Event Description

The beckman field service engineer (fse) reported a laceration on the right wrist during an installation of the dxa analyzer.The incident occurred when fse was tightening the locknut with a wrench and the wrench slipped.The fse was wearing gloves at the time of the injury.The fse applied a band-aid to stop the bleeding and went to emergency room for treatment of the laceration.The fse was not prescribed any medication and did not miss any work due to the injury.There was no report of death associated with this event.

• Brand Name: DXA-INPUT-OUTPUT-DEC
• 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: alexander schwiersch ; sauerbruchstr. 50; münchen 81377 ; GM 81377
• MDR Report Key: 18576779
• MDR Text Key: 333659180
• Report Number: 3006655511-2024-00001
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590739942
• UDI-Public: (01)15099590739942(11)231005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DXA-INPUT-OUTPUT-DEC
• Device Catalogue Number: C44570
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2023
• 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