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

Model Number	08H67-03
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 depressed hemoglobin results generated on the cell dyn ruby instrument.The following data was provided: sample tested multiple times: 8.9 g/dl, 9.3 g/dl, 9.25 g/dl and 6.8 g/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of all complaints associated and a review of complaint trends for the list number was performed.The review did not identify any trends or a product issue could not be identified.Additionally, labeling was reviewed and adequately addressed the issue under review.Based on the information provided, a cause could not be determined; preanalytical factors and sample pathology could not be ruled out.Digital voltage readings were verified, and repeatability tests with quality controls were run.No additional issues were reported.Based on the investigation, no deficiency 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16132988
• Report Number: 2919069-2023-00002
• Device Sequence Number: 7636319
• 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): 02/09/2023

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 Model Number: 08H67-03
• Device Catalogue Number: 08H67-03
• Device Lot Number: 54994BG96
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2016
• 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