MAUDE Adverse Event Report: BECKMAN COULTER, INC. MICROSCAN KOVAC'S REAGENT; GRAM NEGATIVE IDENTIFICATION PANEL

Model Number	RGNT KOVAC'S 30ML
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer in japan reported one bottle of b1010-41a microscan kovac¿s reagent lot 2026-11-13 arrived leaking.The package arrived with the outer packaging contaminated with the reagent.Upon inspection of the bottle, it was noted the cap was insufficiently tightened and shrink-wrapped to the bottle in a tilted state.At the time of discovery, the odor of the leaked reagent was extremely strong, and two staff members felt unwell reporting ongoing cold-like symptoms, eye and respiratory irritation.One of the two exposed staff members did seek out medical attention and was prescribed medication.Both staff members have fully recovered.
Additional Manufacturer Narrative
Beckman coulter complaint handling unit investigator (chu) reviewed the event information and two photos that were provided.One photo showed the cap shrink-wrapped crooked on the bottle.The box in the photo had evidence of reagent leakage based on the yellow-colored stain.The second photo again demonstrated stain from leaked reagent on the product box.Device history record (dhr) was reviewed for b1010-41a kovac¿s reagent 30ml lot 2026-11-13.No anomalies during manufacturing were noted.All cap torque measurements were within specification.No damaged or leaking bottles were observed during quality control inspection.Lot met all final quality control criteria prior to release.Retention inspection was performed on b1010-41a kovac¿s reagent 30ml lot 2026-11-13.The retention sample was fully filled with no signs of damage or leakage, the cap was correctly placed, and the bottle shrink wrapping was secure.The customer was provided with a replacement of kovac¿s reagent and no further issues were reported.Section a2, a3, a4, a5 and a6: information not provided by customer.Section e1, initial reporter telephone number is (b)(6).The beckman coulter internal identifier is (b)(4).

• Brand Name: MICROSCAN KOVAC'S REAGENT
• Common Device Name: GRAM NEGATIVE IDENTIFICATION PANEL
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 2040 enterprise blvd.; west sacramento CA 95691
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 25059416
• Report Number: 2919016-2026-00001
• Device Sequence Number: 10101189
• Product Code: LQM
• UDI-Device Identifier: 15099590655204
• UDI-Public: (01)15099590655204(17)261113(11)251113(10)2026-11-13
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 05/01/2026

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: RGNT KOVAC'S 30ML
• Device Catalogue Number: B1010-41A
• 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: 04/16/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2025
• 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