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	03/27/2026
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.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer reported falsely depressed neutrophils generated on the alinity hq processing module for a 75-year-old male patient.The following data was provided (units of measure provided: 10e9/l): (b)(6) 2026, sid: (b)(6): (b)(6) result = 0.217 and 0.167, (b)(6) = 2.89.Additional laboratory data was provided: wbc: (b)(6) result = 3.82 and 3.86, (b)(6) = 3.76 hemoglobin: (b)(6) result = 88.7 g/l and 89.7 g/l, (b)(6) = 88.5 g/l platelet: (b)(6) result = 121 and 116, (b)(6) = 115 lymphocytes: (b)(6) result = 0.73 and 0.607s, (b)(6) = 0.662 monocytes: (b)(6) result = 2.78 and 3.04x, (b)(6) = 0.18.Eosinophils: (b)(6) result = 0.043 and 0.027, (b)(6) = 0.007.Basophils: (b)(6) result = 0.05 and 0.042s, (b)(6) = 0.02.A smear slide was reviewed and no blast cells were seen.No impact to patient management was reported.
Event or Problem Description
The customer reported falsely depressed neutrophils generated on the alinity hq processing module for a 75-year-old male patient.The following data was provided (units of measure provided: 10e9/l): (b)(6) 2026, sid: (b)(6): (b)(6) result = 0.217 and 0.167, (b)(6) = 2.89.Additional laboratory data was provided: wbc: (b)(6) result = 3.82 and 3.86, (b)(6)= 3.76, hemoglobin: (b)(6) result = 88.7 g/l and 89.7 g/l, (b)(6) = 88.5 g/l, platelet: (b)(6) result = 121 and 116, (b)(6) = 115, lymphocytes: (b)(6) result = 0.73 and 0.607s, (b)(6) = 0.662, monocytes: (b)(6) result = 2.78 and 3.04x, (b)(6) = 0.18, eosinophils: (b)(6) result = 0.043 and 0.027, (b)(6) = 0.007, basophils: (b)(6) result = 0.05 and 0.042s, (b)(6) = 0.02.A smear slide was reviewed and no blast cells were seen.No impact to patient management was reported.
Additional Manufacturer Narrative
Sections d3 email and g1 mfg site email were updated.Specimen results, flow cytometry standard (fcs) files, and smear images were reviewed.The review found that the hct, mcv, mchc, and rdw parameters were flagged as suspect, and the asym flag was generated for all sample runs.Additionally, the lym, mono, and baso parameters were flagged as suspect/invalid, and the blast flag was generated for the repeat runs.The repeat run on hq00633 generated the mono boundary not found flag.Data flagging (suspect/invalid) was generated for some of the wbc differential parameters, indicating the verification of the results was required.Review of the fcs files found the scatter plots appeared abnormal, with neutrophils showing very low pss values.Review of the smear images confirmed the cells are neutrophils.A review of tracking and trending did not identify any trends.Device history record was reviewed and did not identify any nonconformances related to the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the alinity hq processing module, serial number hq00633 was identified.

• Brand Name: ALINITY HQ ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 24796058
• Report Number: 3016438761-2026-00197
• Device Sequence Number: 15825778
• 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): 04/23/2026

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: 03/27/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/23/2026
• 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 Age: 75 YR
• Patient Sex: Male