MAUDE Adverse Event Report: Abbott Laboratories CELL-DYN Ruby; 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	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased hemoglobin (hgb) results by the cell dyn ruby analyzer for a 82yrs old female patient.The results provided were: on (b)(6) 2026 sid (b)(6) hemoglobin: initial=6.44 g/dl /repeated=6.31 g/dl redrawn and repeated sid (b)(6)=10.1 g/dl.On (b)(6) 2026=9.4 g/dl on (b)(6) 2026=10.2 g/dl on (b)(6)2026=11.0 g/dl on (b)(6) 2026=12.3 g/dl on (b)(6) 2026=10.7 g/dl there was no reported impact to patient management.
Event or Problem Description
The customer observed falsely decreased hemoglobin (hgb) results by the cell dyn ruby analyzer for a 82yrs old female patient.The results provided were: on (b)(6)2026 sid (b)(6) hemoglobin: initial=6.44 g/dl /repeated=6.31 g/dl.Redrawn and repeated sid (b)(6) =10.1 g/dl.On (b)(6)2026=9.4 g/dl.On (b)(6)2026=10.2 g/dl.On (b)(6)2026=11.0 g/dl.On (b)(6)2026=12.3 g/dl.On (b)(6)2026=10.7 g/dl.There was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.No instrument troubleshooting has been performed, and sample integrity cannot be ruled out as a contributing factor to the reported result discrepancy due to the difficulties encountered during sample collection.Review of the instrument service history found no subsequent complaints for discrepant patient hemoglobin results.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of complaints and trending data for cell-dyn ruby analyzer did not identify any similar issues related to the current issue.A review of the manufacturing documentation did not identify any non-conformances and potential non-conformances related to the current issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the cell-dyn ruby analyzer for serial number (b)(6) was identified.

• Brand Name: CELL-DYN Ruby
• Common Device Name: Counter, differential cell
• Manufacturer (Section D): Abbott Laboratories; 647 almanor ave.; sunnyvale CA 94085
• Manufacturer (Section G): Abbott Laboratories; 647 almanor ave.; sunnyvale CA 94085
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; +49()6122582960
• MDR Report Key: 50601572
• Report Number: 2919069-2026-00008
• Device Sequence Number: 16129888
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/24/2026

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): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2017
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female