MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY S SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number	06P16-01
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported false reactive alinity s hiv ag/ab combo generated from alinity s system and provided the following data: sample (b)(6) was tested after the high reactive sample on alinity s system sn: (b)(6) and generated a result of 56.32 s/co (reactive).Sample was re-tested one time on the same analyzer and three times on a different analyzer (sn: (b)(6) and generated reactive results.The customer tested an archived sample from the same individual on sn: (b)(6) and the result was 0.08 s/co (non-reactive).The customer believes that sample (b)(6) gave false reactive results and was contaminated by being tested directly after the high reactive sample (sample (b)(6).Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
Complete information from section a1 patient identifier: sid: (b)(6).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 reported false reactive alinity s hiv ag/ab combo generated from alinity s system and provided the following data: sample (b)(6) was tested after the high reactive sample on alinity s system sn: (b)(6) and generated a result of 56.32 s/co (reactive).Sample was re-tested one time on the same analyzer and three times on a different analyzer (sn: (b)(6) and generated reactive results.The customer tested an archived sample from the same individual on sn: (b)(6) and the result was 0.08 s/co (non-reactive).The customer believes that sample (b)(6) gave false reactive results and was contaminated by being tested directly after the high reactive sample (sample (b)(6).Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
The abbott ambassador inspected the alinity s system serial number (b)(6) and identified that the alnty pptr probes had gel in the tip.The ambassador replaced the alnty pptr probes which resolved the issue.A review of the instrument service history identified no additional issues or contributing factors to the current complaint.There were no additional complaints for alinity s related to the current issue.A review of complaint and trending data for the alinity s system did not identify any trends associated with the complaint issue.Additionally review of complaint and trending data associated with the alnty pptr probes did not identify any trends.The device history record was reviewed, and no nonconformances, potential nonconformances or deviations were identified.The alinity s system operations manual provides adequate information for the removal and replacement of the alnty pptr probes and adequate troubleshooting for the observed issue.Based on the investigation, no systemic issue or deficiency of the alinity s system serial number (b)(6) or the alnty pptr probes were identified.

• Brand Name: ALINITY S SYSTEM
• Common Device Name: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23243967
• Report Number: 1628664-2025-00008
• Device Sequence Number: 18720410
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: (01)00380740138479
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: BL125674
• 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): 12/16/2025

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: 06P16-01
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2018
• 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: ALNTY S HIV COMBO 5000T, 06P01-55, UNKNOWN; ALNTY S HIV COMBO 5000T, 06P01-55, UNKNOWN
• Patient Sex: Unknown