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

Catalog Number	08H67-01
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
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 falsely elevated wbc results and discrepant hemoglobin results generated by the cell-dyn ruby analyzer for a patient, which were inconsistent with the results from the sysmex.The blood smear was reviewed and showed the presence of nucleated rbcs (nrbcs).The following data were provided: on (b)(6) 2025 sample id: (b)(6) sequence#: 4570 (cbc+ rrbc test mode).Ruby wbc result = 92.7 x 10e3/ l (invalidated with an asterisk).Ruby hgb result = 8.15 g/dl.Flags present: (noc)wbc, fwbc/nwbc, dflt (nlmeb), var lym, rbc morph.The customer released the results from sequence #4570 out of the lab.Upon reviewing the blood smear, numerous nrbcs were seen.The sample was repeated on the cell-dyn ruby in cbc + noc test mode as well as on the sysmex platform.The following data were provided: on (b)(6) 2025 sample id: (b)(6) sequence#: 4571 (cbc+ noc test mode).Ruby wbc result = 89.5 x 10e3/ l.Ruby hgb result = 7.25 g/dl.Flags present: noc, fwbc, dflt (nlmeb), rbc morph.On (b)(6) 2025 sysmex results: wbc = 16.31 x 10e3/ l.Hgb = 5.8 g/dl.Flags present: wbc abn scattergram, lymphocytosis, monocytosis, nrbc present, ig present, blasts/abn lympho, anisocytosis, macrocytosis, anemia, plt clumps.There was no impact to patient management reported.
Event or Problem Description
The customer observed falsely elevated wbc results and discrepant hemoglobin results generated by the cell-dyn ruby analyzer for a patient, which were inconsistent with the results from the sysmex.The blood smear was reviewed and showed the presence of nucleated rbcs (nrbcs).The following data were provided: (b)(6) 2025 sample id: (b)(6) sequence# 4570 (cbc+ rrbc test mode).Ruby wbc result = 92.7 x 10e3/¿l (invalidated with an asterisk).Ruby hgb result = 8.15 g/dl.Flags present: (noc)wbc, fwbc/nwbc, dflt (nlmeb), var lym, rbc morph the customer released the results from sequence #4570 out of the lab.Upon reviewing the blood smear, numerous nrbcs were seen.The sample was repeated on the cell-dyn ruby in cbc + noc test mode as well as on the sysmex platform.The following data were provided: (b)(6) 2025 sample id: (b)(6).Sequence# 4571 (cbc+ noc test mode).Ruby wbc result = 89.5 x 10e3/¿l.Ruby hgb result = 7.25 g/dl.Flags present: noc, fwbc, dflt (nlmeb), rbc morph.(b)(6) 2025 sysmex results: wbc = 16.31 x 10e3/¿l hgb = 5.8 g/dl flags present: wbc abn scattergram, lymphocytosis, monocytosis, nrbc present, ig present, blasts/abn lympho, anisocytosis, macrocytosis, anemia, plt clumps.There was no impact to patient management reported.
Additional Manufacturer Narrative
The cell-dyn ruby analyzer, serial number (b)(6), was considered the likely cause of the result issue as a single definitive part could not be determined and no troubleshooting was performed.The sample was tested in both the cbc + rrbc and cbc + noc test modes with consistently elevated wbc results on the ruby; however, there was suspect flagging on the wbc results and other parameters.A smear review showed the presence of nrbcs.An instrument service history for the 70226bg found no additional complaints of discrepant wbc, or hgb reported after the current event was identified.A review of the cell-dyn ruby analyzer (list number 08h67-01), did not identify an increase in complaint activity related to the current issue.The device history record was reviewed, and no non-conformances or potential non-conformances were identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the cell-dyn ruby analyzer, serial number (b)(6), was identified.

• Brand Name: CELL-DYN RUBY
• 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: 21729864
• Report Number: 2919069-2025-00013
• Device Sequence Number: 8789971
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 04/21/2025

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: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2016
• 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