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

Catalog Number	08H67-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
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.All available patient information has been included.No additional patient details are available.
Event or Problem Description
The customer observed imprecise hemoglobin results generated on the cell dyn ruby analyzer.The following data was provided (normal range 12 to 14.5): samples from one patient: april 14 12.7.April 14 8.7.April 15 8.5.April 16 8.6.April 16 7.8.April 17 9.1.April 17 8.6.April 17 9.1.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and the hgb flow cell assembly was replaced, resolving the issue.Return testing was not completed as returns were not available.A review of tracking and trending for the cell-dyn ruby analyzer did not identify any trends.A review of tracking and trending for the hgb flow cell assembly did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the cell-dyn ruby analyzer for serial 55516bg or the hgb flow cell assembly were identified.
Event or Problem Description
The customer observed imprecise hemoglobin results generated on the cell dyn ruby analyzer.The following data was provided (normal range 12 to 14.5): samples from one patient: april 14 12.7, april 14 8.7, april 15 8.5, april 16 8.6, april 16 7.8, april 17 9.1, april 17 8.6, april 17 9.1.No impact to patient management was reported.

• 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: 19310269
• Report Number: 2919069-2024-00034
• Device Sequence Number: 6911625
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)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): 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): 08/06/2024

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): Initial
• Initial Date Received by Manufacturer: 04/27/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2015
• 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