MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN SAPPHIRE; COUNTER, DIFFERENTIAL CELL

Catalog Number	08H00-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed an asterisk (*) and a short sample message for all samples generated on the cell-dyn sapphire analyzer.The hbg cup and rbc cup did not drain and reported the wash cup (wc) #4 and wc #3 was full.The customer reported two users were sprayed in the face with liquid from the left flow panel while observing.The customer mentioned the users did not take any actions after being sprayed in the face with the liquid.No impact to patient management or impact to user safety was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and manufacturing documentation review.Return testing was not completed as returns were not available.Data and information provided by the customer was reviewed.A review of complaint and trending data for the cell-dyn sapphire analyzer did not identify any similar issues related to the with regards to the current issue.Additionally review of complaint and trending data associated with the tubing, silicon,.062 inch id x.094 inch od, (s2) did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the cell-dyn sapphire analyzer for serial number (b)(6) was identified.
Event or Problem Description
The customer observed an asterisk (*) and a short sample message for all samples generated on the cell-dyn sapphire analyzer.The hbg cup and rbc cup did not drain and reported the wash cup (wc) #4 and wc #3 was full.The customer reported two users were sprayed in the face with liquid from the left flow panel while observing.The customer mentioned the users did not take any actions after being sprayed in the face with the liquid.No impact to patient management or impact to user safety was reported.

• Brand Name: CELL-DYN SAPPHIRE
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 22211362
• Report Number: 2919069-2025-00023
• Device Sequence Number: 8660225
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: (01)00380740016616
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K051215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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 Catalogue Number: 08H00-01
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2014
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TUBING, SILICON, .062 INCH ID X .094 INCH OD, (S2).
• Patient Sex: Unknown