MAUDE Adverse Event Report: Beckman Coulter, Inc AU5800 Clinical Chemistry Analyzer; Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Model Number	AU5800-20 CHEMISTRY ANALYZER AU5800 Automation Ready
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The beckman field service engineer (fse) sustained a fingernail injury during the de-installation of the au5800 analyzer.The fse sought medical attention at the emergency room, where cefprozil was prescribed to treat the damaged nail.The fse was wearing gloves at the time of the incident.The fse was able to return to work the following day without any restrictions.There was no death associated with this event.
Additional Manufacturer Narrative
There was no evidence of an analyzer malfunction for this event.The fse reported an injury while performing the de-installation.The fse indicated while lifting a floor panel, it detached and fell onto the fse¿s finger.The fse received medication and returned to work the next day without any restriction.Based on the available information, the cause was an accidental injury.Section a2, a3, a4, and a5: information not provided by customer.Beckman coulter internal identifier is (b)(4).

• Brand Name: AU5800 Clinical Chemistry Analyzer
• Common Device Name: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
• Manufacturer (Section D): Beckman Coulter, Inc; 250 s. kraemer blvd.; brea CA 92821 -800
• Manufacturer (Section G): Beckman Coulter Mishima K.K.; 454-32 higashino; nagaizumi-cho sunto-gun; schizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; +1(952)491-6938
• MDR Report Key: 50024556
• Report Number: 9612296-2026-00285
• Device Sequence Number: 10540144
• Product Code: JJE
• UDI-Device Identifier: 14987666543023
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K112412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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
• Operator of Device: Health Professional
• Device Model Number: AU5800-20 CHEMISTRY ANALYZER AU5800 Automation Ready
• Device Catalogue Number: B96698
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown