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

Catalog Number	09P68-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
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.All available patient information has been included.No additional patient details are available.
Event or Problem Description
The customer observed falsely elevated hematocrit results generated on the alinity hq processing module.The following data was provided: initial result 0.75 and 0.7, repeats at 0.4.No incorrect results were reported out.No impact to patient management was reported.
Event or Problem Description
The customer observed falsely elevated hematocrit results generated on the alinity hq processing module.The following data was provided: initial result 0.75 and 0.7, repeats at 0.4.No incorrect results were reported out.No impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the alinity hq analyzer serial number (b)(6).The field service representative inspected the analyzer and performed multiple troubleshooting procedures including replacement of worn parts.The alinity hq analyzer serial number (b)(6) was considered the cause of the result issues.Review of tracking and trending did not identify an increase in complaint activity related to the complaint issue.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency was identified.

• 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: 23085925
• Report Number: 2919069-2025-00043
• Device Sequence Number: 10508823
• 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): 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): 10/27/2025

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: 09/10/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• 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