MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S HTLV I/II REAGENT KIT; SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO

Catalog Number	06P07-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false repeat reactive alinity s htlv i/ii results on several patients, which were confirmed negative by western blot testing.The results provided were: on (b)(6) 2025, sid (b)(6), initial=1.30 s/co (> or =1.00 s/co=reactive) /repeated=1.38 s/co and 1.46 s/co.On (b)(6) 2025, sid (b)(6), initial=3.39 s/co /repeated=3.78 s/co and 3.43 s/co /repeated on (b)(6) 2025=0.18 s/co (< 1.00 s/co=nonreactive).On (b)(6) 2025, sid(b)(6), initial=1.80 s/co /repeated=reactive (no actual results provided).On (b)(6) 2025, sid (b)(6), initial=1.64 s/co /repeated=reactive (no actual results provided).On (b)(6) 2025, sid (b)(6), initial=3.78 s/co /repeated=reactive (no actual results provided).On (b)(6) 2025, sid (b)(6), initial=1.25 s/co /repeated=reactive (no actual results provided) there was no reported impact to patient management.
Event or Problem Description
The customer observed false repeat reactive alinity s htlv i/ii results on several patients, which were confirmed negative by western blot testing.The results provided were: on (b)(6) 2025 sid (b)(6) initial=1.30 s/co (> or =1.00 s/co=reactive) /repeated=1.38 s/co and 1.46 s/co on (b)(6) 2025 sid (b)(6) initial=3.39 s/co /repeated=3.78 s/co and 3.43 s/co /repeated on (b)(6) 2025=0.18 s/co (< 1.00 s/co=nonreactive).On (b)(6) 2025 sid (b)(6) initial=1.80 s/co /repeated=reactive (no actual results provided).On (b)(6) 2025 sid (b)(6) initial=1.64 s/co /repeated=reactive (no actual results provided).On (b)(6) 2025 sid (b)(6) initial=3.78 s/co /repeated=reactive (no actual results provided).On (b)(6) 2025 sid (b)(6) initial=1.25 s/co /repeated=reactive (no actual results provided).There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, field data history of alinity s htlv i/ii, list number, lot 64146be00.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of the manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Review of tracking and trending for the alinity s htlv i/ii assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 64146be00.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.The customer data review for alinity s htlv i/ii reagent, lots 64146be00 was performed.The analysis included initial reactive rates (irr), repeat reactive rates (rrr) and specificity (assuming zero prevalence) at ibr, us whole blood (wb) peer sites.At customer site the specificity performance of lot 64146be00 shows variability but within product requirements.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity s htlv i/ii reagent lot 64146be00.

• Brand Name: ALINITY S HTLV I/II REAGENT KIT
• Common Device Name: SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21514828
• Report Number: 3002809144-2025-00069
• Device Sequence Number: 20823787
• Product Code: QHM
• UDI-Device Identifier: 00380740117214
• UDI-Public: (01)00380740117214(17)250630(10)64146BE00
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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 Expiration Date: 06/30/2025
• Device Catalogue Number: 06P07-60
• Device Lot Number: 64146BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6)
• Patient Sex: Unknown