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	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Additional information for section a1 patient identifier: two sample id's were provided for one patient: (b)(6).All available patient information was included.Additional patient details were not provided.
Event or Problem Description
The customer observed a falsely depressed hemoglobin result generated on an alinity hq processing module, (b)(6), which repeated higher on another alinity hq processing module, (b)(6) for a 48-year-old male patient.Sid (b)(6): hgb initial result = 5.44l g/dl, repeat result sid (b)(6) = 8.04l g/dl the results generated on (b)(6) were not reported out of the lab.There was no impact to patient managment.
Additional Manufacturer Narrative
Service performed multiple troubleshooting procedures which resolved the issue and was confirmed with a successful control and precision run.Tracking and trending review for the alinity hq did not identify any trends nor an increase in complaint activity.Labeling was reviewed and adequately addresses the complaint issue.Based on the investigation, no systemic issue or deficiency was identified for the alinity hq processing module, (b)(6).
Event or Problem Description
The customer observed a falsely depressed hemoglobin result generated on an alinity hq processing module, (b)(6), which repeated higher on another alinity hq processing module, (b)(6) for a 48-year-old male patient.Sid (b)(6): hgb initial result = 5.44l g/dl, repeat result sid (b)(6) = 8.04l g/dl.The results generated on (b)(6) were not reported out of the lab.There was no impact to patient managment.

• 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: 23779142
• Report Number: 2919069-2025-00049
• Device Sequence Number: 21330262
• 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): 12/30/2025

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: 11/24/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2019
• 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 Age: 48 YR
• Patient Sex: Male