MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HCV REAGENT KIT; SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO

Catalog Number	06P04-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Completed information for section a1 - patient identifier: sids (b)(6); all available patient information was included.Additional patient details are not available.The complaint investigation for false reactive alinity s anti-hcv results 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.A review of tracking and trending did not identify any trends for the issue for the product.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 6p04-60, lot number 62159be00, at the customer¿s site, applicable peer sites, and across all 6p04 (ous) customer sites were collected and assessed.Across all 6p04 (ous) blood screening customers, the initial reactive rate (irr), repeat reactive rate (rrr) and specificity (assuming zero prevalence) observed for lot 62159be00 are within product requirements and comparable to other lots analyzed in comparison.Whole blood and plasma monitoring group: irr: 0.077%, rrr: 0.075%, irr - rrr: 0.001%, specificity: 99.925%.Peer sites: irr: 0.186%, rrr: 0.183%, irr - rrr: 0.004%, specificity: 99.817%.Customer¿s site: irr: 0.079%, rrr: 0.075%, irr - rrr: 0.004%, specificity: 99.925%.A malfunction was not identified.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-hcv reagent lot 62159be00 is performing as intended.No systemic issue or deficiency of the alinity s anti-hcv reagent was identified.
Event or Problem Description
The customer observed false repeat reactive alinity s anti-hcv results for donor samples which were not consistent with nat testing.The following data was provided (<1.00 s/co is nonreactive, = 1.00 s/co is reactive): sample id (b)(6) collected on (b)(6) 2024 (b)(6) 2024 sample run and results are repeat reactive.Initial result on analyzer (b)(6) = 2.32 s/co, repeat results on analyzer (b)(6) = 2.65 s/co, 2.79 s/co nat result on cobas = nonreactive confirmatory ortho eia result = reactive sample tested on all three in-house alinity analyzers on (b)(6) 2025 for anti-hcv ii and all 3 results = nonreactive x3 as follows: result on as1233 = 0.03, result on as1234 = 0.03, result on as1215 = 0.04 sample id (b)(6) collected on (b)(6) 2024 (b)(6) 2024 sample run and results are repeat reactive.Initial result = 2.19 s/co, repeat results = 2.28 s/co, 2.37 s/co nat result on cobas = nonreactive confirmatory ortho eia result = reactive sample tested on all three in-house alinity analyzers on (b)(6) 2025 for anti-hcv ii and all 3 results = nonreactive x3 as follows: result on (b)(6) = 0.03, result on (b)(6) = 0.03, result on (b)(6) = 0.04 there was no impact to donor or patient management reported.

• Brand Name: ALINITY S ANTI-HCV 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: 21266198
• Report Number: 3002809144-2025-00027
• Device Sequence Number: 3664722
• Product Code: QHM
• UDI-Device Identifier: 00380740117191
• UDI-Public: (01)00380740117191(17)250214(10)62159BE00
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: BL125677
• 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
• Report Date (Section B): 01/29/2025

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: 02/14/2025
• Device Catalogue Number: 06P04-60
• Device Lot Number: 62159BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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