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

Catalog Number	08H67-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
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 a falsely depressed hemoglobin cell-dyn ruby result when compared to the alinity hq result for one patient.The following data was provided: ruby hemoglobin = 7.85 g/dl alinity hq hemoglobin = 8.71 g/dl there was no impact to patient management reported.
Additional Manufacturer Narrative
The customer reported falsely depressed results for one patient sample on the cell-dyn ruby, serial number (s/n) (b)(6)when compared to the alinity hq instrument.Based on the information provided,hgb control values for (b)(6)are recovering within the expected range, and recovery values are similar to the customer¿s peer group.Due to the difference in technology between the cell-dyn ruby and the alinity hq, it is expected to encounter differences on the results between the analyzers.A review of all complaints associated and a review of complaint trends for the list number was performed.The review did not identify any adverse trends.Additionally, labeling was reviewed and adequately addressed the issue under review.Based on the investigation, no systemic issue or deficiency of the cell-dyn ruby, serial number (s/n) (b)(6)was identified.

• Brand Name: CELL-DYN RUBY 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden N39 E-932 ; GM N39 E932 ; 6122582960
• MDR Report Key: 18588033
• Report Number: 2919069-2024-00010
• Device Sequence Number: 17926936
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K061667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2017
• 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