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

Model Number DXA 5000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

The fse received prescription pain medication and was on sick leave until (b)(6) 2021.The fse has since fully recovered from the injury and is back on duty without reporting any further complications due to the incident.The customer is operational and no further contact is required.Assessment of the available information revealed, that during the reattachment of the side panel of the output module, the fse did not follow instructions of the current dxa service manual section "5.3.7.3 mounting the side covers" which instructs the installation of the side panels to be performed by two (2) people.(b)(6).The beckman coulter internal identifier is (b)(4).

Event Description

During repair of a push cap feeder error the beckman coulter fse (field service engineer) sustained a shoulder injury whilst reattaching the side panel of the dxa output module.The fse received prescription pain medication and was on sick leave until (b)(6) 2021.No hospitalization was required.The fse since has recovered from the injury.No erroneous patient results were generated due to this incident.

• Brand Name: DXA
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER BIOMEDICAL GMBH; sauerbruchstr 50; münchen 81377 ; GM 81377
• MDR Report Key: 12691229
• MDR Text Key: 281739948
• Report Number: 3006655511-2021-00003
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590720261
• UDI-Public: (01)15099590720261(11)191218
• Combination Product (y/n): N
• PMA/PMN Number: K190298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 10/25/2021

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: DXA 5000
• Device Catalogue Number: B87344
• Device Lot Number: 65269326
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other