MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S HIV AG/AB COMBO REAGENT KIT; SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO

Catalog Number	06P01-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
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 observed false repeat reactive alinity s hiv ag/ab combo results for two donors, which were not consistent with the donors¿ previous results.In addition, both donors were nat negative (cobas 800).The following data was provided (<1.00 s/co is nonreactive, = 1.00 s/co is reactive): sid (b)(6): on (b)(6) 2025, initial result = 9.29 s/co (lot 65260be00), on (b)(6)2025, repeat results = 8.95 s/co (lot 65260be00), 7.62 s/co (lot 65260be00), 6.07 s/co (lot 63242be00).Nat testing (cobas 800) = negative.Historical results = negative.Sid (b)(6): on (b)(6)2025, initial result = 1.79 s/co (lot 65260be00), on (b)(6) 2025, repeat results = 2.06 s/co (lot 65260be00), 1.89 s/co (lot 65260be00), 0.82 s/co (lot 63242be00).Nat testing (cobas 800) = negative, historical results = negative, there was no impact to donor management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, a search for similar complaints, a ticket trending review, a device history record review, a labeling review, and a field data review.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and supported the complaint issue without indication of any additional issues.A review of tracking and trending for the product and the likely cause, lot 65260be00, did not identify an increase in complaint activity.A review of the device history record did not identify any non-conformances or deviations with lot 65260be00 and the complaint issue.A review of field data for alinity s hiv ag/ab combo was performed.The overall reactive rates of ln 6p01-60, lot 65260be00, across bloodworks northwest (usa), applicable peer sites and across a whole blood and plasma monitoring group were collected and assessed.Across the whole blood and plasma monitoring group, the customer and their peer sites, the performance of lot 65260be00 is within product requirements.Lot 65260be00 has comparable performance to other lots analyzed in the comparison for the whole blood and plasma monitoring group and peer sites.A review of labeling was performed and found to sufficiently address the customer¿s issue.Based on the investigation, no systemic issue or deficiency was identified.The alinity s hiv ag/ab combo reagent, lot number 65260be00, is performing as expected.
Event or Problem Description
The customer observed false repeat reactive alinity s hiv ag/ab combo results for two donors, which were not consistent with the donors¿ previous results.In addition, both donors were nat negative (cobas 800).The following data was provided (<1.00 s/co is nonreactive, = 1.00 s/co is reactive): sid (b)(6): on (b)(6) 2025 initial result = 9.29 s/co (lot 65260be00).On (b)(6) 2025 repeat results = 8.95 s/co (lot 65260be00), 7.62 s/co (lot 65260be00), 6.07 s/co (lot 63242be00).Nat testing (cobas 800) = negative.Historical results = negative.Sid (b)(6): on (b)(6) 2025 initial result = 1.79 s/co (lot 65260be00).On (b)(6) 2025 repeat results = 2.06 s/co (lot 65260be00), 1.89 s/co (lot 65260be00), 0.82 s/co (lot 63242be00).Nat testing (cobas 800) = negative historical results = negative there was no impact to donor management reported.

• Brand Name: ALINITY S HIV AG/AB COMBO 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: 21218679
• Report Number: 3002809144-2025-00016
• Device Sequence Number: 16975777
• Product Code: QHM
• UDI-Device Identifier: 00380740117184
• UDI-Public: (01)00380740117184(17)250611(10)65260BE00
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: BL125679
• 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): 02/05/2025

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: 06/11/2025
• Device Catalogue Number: 06P01-60
• Device Lot Number: 65260BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2025
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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 SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6)
• Patient Sex: Unknown