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	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1: patient identifier: sids: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely decreased neutrophil and hemoglobin results generated by the alinity hq analyzer for two patients.The results were released out of the lab.The samples were repeated yielding higher results.The following data was provided: patient (b)(6): on (b)(6) 2025, sid: (b)(6): hgb: initial result = 5.56 g/dl, repeat result = 10.6 g/dl.Patient (b)(6): on (b)(6) 2025, sid: (b)(6): neu: initial result = 0.472 x 10e3/l, repeat result = 0.942 x 10e3/l.Hgb: initial result = 6.52 g/dl (hgb interference flag), repeat result = 14.1 g/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) performed troubleshooting on the alinity hq processing module, serial number (b)(6) and replaced multiple parts for leaking, clogged and proactively.The replacement of the valve-check, inline, ppro; valve assy, 2-way, n/c, epdm seal, 24vdc, smc lvm15; assy, waste btl, 1l, float level switch, ppro; tubing kit 4, kit s2109; and ftg tbg vlv chk.062 inch duck bill resolved the issue.The instrument service history for the alinity hq processing module verifies no subsequent complaints have been reported related to discrepant hemoglobin patient results.A review of tracking and trending did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances related to the alinity hq and customer reported event.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the alinity hq processing module, serial number (b)(6), or the valve-check, inline, ppro; valve assy, 2-way, n/c, epdm seal, 24vdc, smc lvm15; assy, waste btl, 1l, float level switch, ppro; tubing kit 4, kit s2109; and ftg tbg vlv chk.062 inch duck bill was identified.
Event or Problem Description
The customer reported falsely decreased neutrophil and hemoglobin results generated by the alinity hq analyzer for two patients.The results were released out of the lab.The samples were repeated yielding higher results.The following data was provided: patient 1: (b)(6) 2025, sid (b)(6): hgb: initial result = 5.56 g/dl, repeat result = 10.6 g/dl.Patient 2: (b)(6) 2025, sid (b)(6): neu: initial result = 0.472 x 10e3/l, repeat result = 0.942 x 10e3/l hgb: initial result = 6.52 g/dl (hgb interference flag), repeat result = 14.1 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: 23051138
• Report Number: 2919069-2025-00040
• Device Sequence Number: 10038507
• Product Code: GKZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: (01)00380740138851
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 11/04/2025

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: 09/02/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2021
• 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