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	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed false repeat reactive alinity s htlv i/ii results for multiple donor samples that were western blot negative.The customer noted an increase in reactive results recently.No specific donor information or data was provided.No impact to patient management was reported.
Event or Problem Description
The customer observed false repeat reactive alinity s htlv i/ii results for multiple donor samples that were western blot negative.The customer noted an increase in reactive results recently.No specific donor information or data was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, field data review, and device history record review.Return testing was not completed as returns were not available.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 62476be00.Device history record review did not identify any non-conformances, potential non-conformances, or deviations with the complaint lot and issue.Labeling was reviewed and sufficiently addresses the customer's issue.The overall reactive rates of ln 6p07-60, lot number 62476be00, at the customer¿s site, applicable peer sites, and across a whole blood and plasma screening monitoring group were collected and assessed.Across all 6p07 (ous) blood screening customers, the initial reactive rate (irr), repeat reactive rate (rrr) and specificity (assuming zero prevalence) observed for lot 62476be00 are within product requirements and comparable to other lots analyzed in comparison.Whole blood and plasma monitoring group: lot 62476be00: irr: 0.049%, rrr: 0.039%, irr - rrr: 0.010%, specificity: 99.961% peer sites: lot 62476be00: irr: 0.063%, rrr: 0.042%, irr - rrr: 0.021%, specificity: 99.958% customer¿s site: lot 62476be00: irr: 0.089%, rrr: 0.071%, irr - rrr: 0.018%, specificity: 99.929% additionally at the customer site, ln 6p07-60 data was reviewed.An increase of repeat reactive rate and a decrease in % specificity (assuming 0 prevalence) is observed to have started in august 2024.The repeat reactive rate increased between october 2024 to january 2025, correlating to the decreased % specificity observed.It is important to note the sample testing volume at gre is low which may impact rate calculations.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.Based on the investigation the alinity s anti-htlv i/ii reagent lot 62476be00 is performing as intended.No systemic issue or deficiency of the alinity s anti-htlv i/ii reagent was identified.

• 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: 21445225
• Report Number: 3002809144-2025-00052
• Device Sequence Number: 7724310
• Product Code: QHM
• UDI-Device Identifier: 00380740117214
• UDI-Public: (01)00380740117214(17)250521(10)62476BE00
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: BL125675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: 05/21/2025
• Device Catalogue Number: 06P07-60
• Device Lot Number: 62476BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY S HTLV I/II 5000T, 06P07-60, 58008BE00; ALNTY S HTLV I/II 5000T, 06P07-60, 58008BE00; ALNTY S HTLV I/II 5000T, 06P07-60, 59282BE00; ALNTY S HTLV I/II 5000T, 06P07-60, 59282BE00; ALNTY S HTLV I/II 5000T, 06P07-60, 61222BE00; ALNTY S HTLV I/II 5000T, 06P07-60, 61222BE00; ALNTY S SYSTEM, 06P16-01, AS1300; ALNTY S SYSTEM, 06P16-01, AS1300
• Patient Sex: Unknown