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

Catalog Number	09P68-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information, multiple patient identifiers are (b)(6).No additional patient information was provided.An evaluation is in process.A followup report will be submitted when the evaluation is compete.
Event or Problem Description
The customer observed imprecise hemoglobin (hgb) results when processing on the alinity hq processing module.Customer normal range: 12 to 16 g/dl sid (b)(6): hgb 8.59, repeat 6.72 g/dl.Sid (b)(6): hgb 10.20, repeat 7.80 g/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and found five waste check valves and vacuum valve 7 were clogged.The valve-check, inline, ppro was replaced, which resolved the issue.A review of tracking and trending for the alinity hq processing module did not identify an increase in complaint activity.A review of tracking and trending for the valve-check, inline, ppro did not identify an increase in complaint activity.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity hq processing module for serial (b)(6) or the valve-check, inline, ppro were identified.
Event or Problem Description
The customer observed imprecise hemoglobin (hgb) results when processing on the alinity hq processing module.Customer normal range: 12 to 16 g/dl sid (b)(6): hgb 8.59, repeat 6.72 g/dl.Sid (b)(6): hgb 10.20, repeat 7.80 g/dl.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: 22881708
• Report Number: 2919069-2025-00037
• Device Sequence Number: 21105072
• Product Code: GKZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: (01)00380740138851
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K220031
• 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): 09/16/2025

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: 08/12/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/24/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2022
• 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