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	06/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier: sids = (b)(6).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 decreased wbc result generated on the cell-dyn sapphire analyzer for three patients.The samples were repeated on another sapphire analyzer which yielded normal results.It was noted that the analyzer did not generate any flag on the initial results.The following data was provided: sid (b)(6) initial wbc result = 0.06 10e3/ul, repeat result (another sapphire) = 7.64 10e3/ul; sid (b)(6) initial wbc result = 0.009 10e3/ul; repeat result (another sapphire) = 5.47 10e3/ul; sid (b)(6) initial wbc result = 0.8 10e3/ul; repeat result (another sapphire) = 6.1 10e3/ul; customer¿s reference range: 4.8 to 10.8 10e3/ul no impact to patient management was reported.
Additional Manufacturer Narrative
Specimen results for 2 sids were submitted for review.Review of the data for sequence # 9249 found that the wbc and wbc differential results were flagged as invalid and flags were generated, indicating that verification of the results was required.Review of the data for sequence # 9281 found that the wbc result was underlined, indicating that the result was below the lower range limit and no results were generated for the wbc differential parameters.The samples were repeated on another cell-dyn sapphire with correct results.The data submitted illustrated the complaint issue.The field service representative (fsr) inspected the instrument and performed troubleshooting including replacement of parts.However, the fsr was unable to determine a single definitive likely cause for the falsely decreased wbc results.A review of tracking and trending of the product list number and complaint activity did not identify any trends for cell-dyn sapphire instrument with regards to the current issue.The device history records were reviewed, and no non-conformances were identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the cell-dyn sapphire for serial number (b)(6) was identified.
Event or Problem Description
The customer observed falsely decreased wbc result generated on the cell-dyn sapphire analyzer for three patients.The samples were repeated on another sapphire analyzer which yielded normal results.It was noted that the analyzer did not generate any flag on the initial results.The following data was provided: sid (b)(6) initial wbc result = 0.06 10e3/ul, repeat result (another sapphire) = 7.64 10e3/ul.Sid (b)(6) initial wbc result = 0.009 10e3/ul; repeat result (another sapphire) = 5.47 10e3/ul.Sid (b)(6) initial wbc result = 0.8 10e3/ul; repeat result (another sapphire) = 6.1 10e3/ul.Customer¿s reference range: 4.8 to 10.8 10e3/ul no impact to patient management was reported.

• 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: 17266471
• Report Number: 2919069-2023-00020
• Device Sequence Number: 12740662
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2023

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: 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): Follow-Up
• Initial Date Received by Manufacturer: 06/17/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• 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