MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY HQ ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number	09P68-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased wbc results generated by the alinity hq analyzer for multiple patients.No system flags or error messages were observed.The following data was provided: initial wbc result = 0 x 10e9/l; repeat result = 3.0 x 10e9/l.Expected wbc result for this patient: 10 x 10e9/l.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The abbott field service representative (fsr) inspected the module, suspected a clot in the flowcell and performed multiple troubleshooting procedures including cleaning of the flowcell, the mixing lines and bleaching cups to resolve the issue.Issue resolution confirmed with passing qc and precision runs.A review of trending data associated with the alinity hq analyzer did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the alinity hq analyzer for serial number (b)(6) was identified.
Event or Problem Description
The customer observed falsely decreased wbc results generated by the alinity hq analyzer for multiple patients.No system flags or error messages were observed.The following data was provided: initial wbc result = 0 x 10e9/l; repeat result = 3.0 x 10e9/l, expected wbc result for this patient: 10 x 10e9/l, no impact to patient management was reported.

• Brand Name: ALINITY HQ ANALYZER
• 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: 22813754
• Report Number: 2919069-2025-00034
• Device Sequence Number: 8703526
• Product Code: GKZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: (01)00380740138851
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K220031
• 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): 09/10/2025

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: 09P68-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2020
• 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