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

Catalog Number	08H67-03
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
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 discrepant white blood cell (wbc) count results for a leukemia patient on a cell-dyn ruby analyzer.The following data was provided: sample id (b)(6) result, on (b)(6) 2023, using noc mode was 55.7 10e3/ul.The patient was recollected on (b)(6) 2023, and the initial result was 7.32 10e3/ul, the sample was repeated in noc mode and the result was 25.1 10e3/ul.The patient¿s sample was sent to another laboratory and the wbc result was 16.6 g/i.All cbc data provided was reviewed and no other parameters meet reporting criteria.There was no impact to patient management reported.
Event or Problem Description
The customer observed discrepant white blood cell (wbc) count results for a leukemia patient on a cell-dyn ruby analyzer.The following data was provided: sample id (b)(6) result, on (b)(6) 2023, using noc mode was 55.7 10e3/ul.The patient was recollected on (b)(6) 2023, and the initial result was 7.32 10e3/ul, the sample was repeated in noc mode and the result was 25.1 10e3/ul.The patient¿s sample was sent to another laboratory and the wbc result was 16.6 g/i.All cbc data provided was reviewed and no other parameters meet reporting criteria.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely decreased wbc results generated on the cell-dyn ruby analyzer, serial number (b)(6), included a review of data and information provided by the customer, search for similar complaints, ticket trending review, and labeling review.Trending review determined no related trend for the product.Return testing was not completed as returns were not available.The samples were from a chronic lymphocytic leukemia (cll) patient.Cll samples often contain fragile wbcs.Samples containing fragile wbc are difficult to measure accurately because of the rapid breakdown of cells during the measurement process.The second sample was tested on a different instrument in another laboratory.The instrument model was unknown; therefore, a comparison of the results between this instrument and cd ruby could not be done.Noc is considered as a measurement specific to cell-dyn ruby.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency with the cell-dyn ruby analyzer, serial number (b)(6), was identified.Section g1 contact information was updated to reflect the current contact (b)(6).

• 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 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17577783
• Report Number: 2919069-2023-00026
• Device Sequence Number: 21052156
• Product Code: GKZ
• UDI-Device Identifier: 00380740099916
• UDI-Public: 00380740099916
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K061667
• 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): 11/21/2023

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: 08H67-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• 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