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	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely decreased hemoglobin results generated on the alinity hq processing module for multiple patients when compared to the customer¿s other hq module (hq01051).The following data was provided: testing was performed on (b)(6) 2026: sample id (b)(6): hemoglobin (hq00731): 6.27; repeat result on same analyzer: 14.5; hemoglobin result (hq01051): 14.2.Sample id (b)(6): hemoglobin result (hq00731): 6.55; hemoglobin result (hq01051): 15.2.Reference range for hemoglobin: 11.50 - 16.1 g/dl there was no impact to patient management reported.
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 decreased hemoglobin results generated on the alinity hq processing module for multiple patients when compared to the customer¿s other hq module (b)(6).The following data was provided: testing was performed on (b)(6) 2026: sample id (b)(6) (77-year-old, male): hemoglobin (b)(6): 6.27; repeat result on same analyzer: 14.5; hemoglobin result (b)(6): 14.2.Sample id (b)(6) (61-year-old, female): hemoglobin result (b)(6): 6.55; hemoglobin result (b)(6): 15.2.Reference range for hemoglobin: 11.50 - 16.1 g/dl.There was no impact to patient management reported.
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.Section b5: additional patient demographics were provided by the customer on (b)(6) 2026.
Event or Problem Description
The customer reported falsely decreased hemoglobin results generated on the alinity hq processing module for multiple patients when compared to the customer¿s other hq module (b)(6).The following data was provided: testing was performed on (b)(6) 2026: sample id (b)(6) (77-year-old, male): hemoglobin (b)(6): 6.27; repeat result on same analyzer: 14.5; hemoglobin result (b)(6): 14.2.Sample id (b)(6) (61-year-old, female): hemoglobin result (b)(6): 6.55; hemoglobin result (b)(6): 15.2.Reference range for hemoglobin: 11.50 - 16.1 g/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the module and found a blockage in the worn valve assy, 2-way, n/c, epdm seal, 24vdc, smc lvm15 (b)(6).The fsr removed the blockage and the issue was resolved.The valve assy was determined to be the cause of the issue.No additional discrepant result issues have been reported since the service activity was completed.The instrument service history review revealed no additional tickets associated with discrepant/erratic patient results.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of trending data associated with the valve assy, 2-way, n/c, epdm seal, 24vdc, smc lvm15 did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity hq processing module, serial number (b)(6) or the valve assy were 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: 24313927
• Report Number: 2919069-2026-00001
• Device Sequence Number: 5650159
• 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,Followup
• Report Date (Section B): 03/31/2026

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: 02/04/2026
• Supplement Date Received by Manufacturer: 02/13/2026; 03/25/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 02/13/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2020
• 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