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)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed discrepant hemoglobin results on cell-dyn ruby analyzer for one patient.The results provided were: initial=7.4 g/dl /repeated=7.8 g/dl /repeated on another ruby (b)(4)=9.4 g/dl /repeated=9.8 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.
Additional Manufacturer Narrative
During the site visit by the field service engineer (fse) the analyzer was inspected and discovered found that the hgb output voltage was outside of specifications.Field service replaced the assy, hgb flow cell, cdruby, rohs, list number 8921292204, lot number unknown.The replacement of the assy, hgb flow cell which resolved the issue.A review of the cell-dyn ruby system operator¿s manual (9212934g¿november 2017) found in section 10, "troubleshooting and diagnostics".The following statements: "generally, conditions that are instrument- or reagent-related will occur on all samples, including controls.Therefore, if a problem is detected or suspected, it is important to confirm instrument performance by rerunning controls.If assistance is needed for any technical or operational problems, call your local country service and support center." this section also provides steps for "troubleshooting imprecise or inaccurate data" including how to gather data and review the x-b tab from the moving average program to verify that the hemoglobin reference values are within 2050 +/- 250.These steps instruct the operator to check the hemoglobin flow cell if the reference value is below 1800 and to call their local country service and support center if the reference value is greater than 2300.Labeling was found to be adequate for the complaint issue.Based on this investigation a product deficiency was not identified for cell-dyn ruby analyzer, list number 08h67-01, serial number (b)(6) or assy, hgb flow cell, cdruby, rohs.

• 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: 14568543
• Report Number: 2919069-2022-00010
• Device Sequence Number: 17617528
• 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): 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): 08/18/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown