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	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed hemoglobin alinity hq results.The result was higher when repeated on another instrument.The following example was provided: alinity (b)(6) sid (b)(6) hemoglobin result = 6.37 repeated on another instrument = 14.6 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.
Event or Problem Description
The customer observed falsely depressed hemoglobin alinity hq results.The result was higher when repeated on another instrument.The following example was provided: alinity (b)(6), sid(b)(6) hemoglobin result = 6.37 repeated on another instrument = 14.6 g/dl there was no impact to patient management reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the alinity hq processing module, serial number (b)(6) and replaced the damaged hq pierce needle.Fsr replacement of the hq pierce needle resolved the issue.The instrument service history review revealed no additional tickets associated with discrepant/erratic hemoglobin 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 tracking and trending for the hq pierce needle did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was found to be adequate for the complaint issue.Based on the available information, no systemic issue or deficiency of the alinity hq processing module, serial number (b)(6) or the hq pierce needle 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: 23500550
• Report Number: 2919069-2025-00046
• Device Sequence Number: 9048438
• Product Code: GKZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: (01)00380740138851
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 12/03/2025

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: 10/22/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALINITY HQ PIERCE NEEDLE, H-35000872-03, UNKNOWN
• Patient Sex: Unknown