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

Model Number	08H00-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an exposure to the face while trouble-shooting a cell-dyn sapphire analyzer.While disconnecting the tubing at v225, the customer was sprayed in the face.The customer was wearing appropriate personal protective equipment (ppe): safety glasses, lab coat, and gloves.The customer stated that the liquid sprayed on the safety glasses only and no medical attention was sought.There was no injury reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation for exposure on a cell-dyn sapphire analyzer, serial number (b)(6), included a review of information provided by the customer, a search for similar complaints, ticket trending review, labeling review, and device history record review.While troubleshooting the analyzer, the customer reported being sprayed in the face while disconnecting the tubing at v225.The customer was wearing appropriate personal protective equipment (ppe).The customer stated the liquid sprayed only on the safety glasses and no medical attention was sought.No subsequent issues have been reported.A review of the instrument history revealed no contributing factors described in this complaint.A review of labeling and historical data was done, and both were adequate, with no trends found.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency was identified.

• Brand Name: CELL-DYN SAPPHIRE SYSTEM
• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15047592
• Report Number: 2919069-2022-00021
• Device Sequence Number: 20162249
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: 08H00-01
• Device Catalogue Number: 08H00-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2014
• 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
• Patient Sex: Unknown