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

Model Number	08H00-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely decreased wbc results for one patient when running on the cell-dyn sapphire analyzer.The following data was provided (wbc normal range: 4.5 ¿ 11.2 x 10e9/l): sid (b)(6): on (b)(6) 2023 = initial wbc result = 0.008 x 10e9/l (8/ul).On (b)(6) 2023 =repeat wbc result = 21.8 x 10e9/l (21800/ul).The hemoglobin and platelet results were provided for reference as they correlate with each other and there is no discrepancy (hemoglobin: initial result = 8.76 / repeat result = 9.3; platelet: initial result = 691 / repeat result = 706).The customer failed to manually review the blood smear of the patient sample to confirm the wbc results.The falsely decreased wbc result was reported to the medical provider, resulted in a bone marrow aspirate/biopsy to be performed on the patient.There was no harm to the patient.There was no additional impact to patient management reported.
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely decreased wbc results for one patient when running on the cell-dyn sapphire analyzer.The following data was provided (wbc normal range: 4.5 ¿ 11.2 x 10e9/l): sid (b)(6): on (b)(6)2023 = initial wbc result = 0.008 x 10e9/l (8/ul) on (b)(6)2023 =repeat wbc result = 21.8 x 10e9/l (21800/ul) the hemoglobin and platelet results were provided for reference as they correlate with each other and there is no discrepancy (hemoglobin: initial result = 8.76 / repeat result = 9.3; platelet: initial result = 691 / repeat result = 706).The customer failed to manually review the blood smear of the patient sample to confirm the wbc results.The falsely decreased wbc result was reported to the medical provider, resulted in a bone marrow aspirate/biopsy to be performed on the patient.There was no harm to the patient.There was no additional impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for observed falsely decreased white blood cell (wbc) results on the cell-dyn sapphire analyzer, serial number (b)(6), included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.Field service did not find any errors concerning sample aspiration fault.A vacuum error caused by clogged tubing was resolved by cleaning and flushing.A review of tracking and trending and did not identify any related trends.A review of device history review and did not identify any non-conformances or deviations related to the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Review of the reports confirmed a dispersional data alert for the initial wbc result, indicating the need for the operator to follow a laboratory protocol, such as repeating the sample, performing a stained blood film review, or notifying the physician.Use error contributed to this event because the customer did not verify the initial result.Based on the investigation, no systemic issue or product deficiency was identified for cell dyn sapphire, serial number (b)(6).

• Brand Name: CELL-DYN SAPPHIRE 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: 17150983
• Report Number: 2919069-2023-00018
• Device Sequence Number: 20338816
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K051215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 08H00-01
• Device Catalogue Number: 08H00-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2011
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown