MAUDE Adverse Event Report: BECKMAN COULTER DXM 1040 MICROSCAN WA INSTRUMENT; INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS

Model Number	DXM 1040 MICROSCAN WA INSTRUMENT
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); Not Applicable (3189)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Beckman coulter field service engineer identified the failure mode to be that the instrument shipped without retaining ring (shaft lock clip) which secures the vertical axis (va) rod.As a result, the counterweight, counter weight rod and vertical axis read assembly slipped causing a near injury to the field service engineer (fse).The fse was not injured as the packaging material caught the counterweight after only 1-inch slip.The fse installed the retaining ring to resolve the issue.The fse verified the instrument is performing within specifications.Also, fse performed total system check-out and performed quality control (qc) diagnostics in customer mode.Information not provided.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
Beckman coulter field service engineer (fse) reported that during the unpacking of the dxm 1040 walkaway instrument, the counterweight, counter weight rod and vertical axis read assembly slipped causing a near injury to the fse due to a missing shaft lock clip.The fse was not injured as the packaging material caught the counterweight after only 1-inch slip.

• Brand Name: DXM 1040 MICROSCAN WA INSTRUMENT
• Common Device Name: INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 10111548
• Report Number: 2919016-2020-00001
• Device Sequence Number: 3540348
• Product Code: LRG
• UDI-Device Identifier: 15099590690885
• UDI-Public: (01)15099590690885(11)200430
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K911400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DXM 1040 MICROSCAN WA INSTRUMENT
• Device Catalogue Number: B1018-440
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1