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

Catalog Number	06P08-50
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (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 reported in the month of(b)(6) 2025, there were 4 false repeat reactive results for alinity s chagas out of 3,131 specimens.Of these, 3 specimens were confirmed as nonreactive by enzyme strip assay (esa) confirmatory testing.The customer provided the following specimen sids for the repeat reactive results: on (b)(6) 2025 sid (b)(6) =repeat reactive /esa=nonreactive on (b)(6) 2025 and (b)(6) 2025 sid (b)(6) =repeat reactive /esa=nonreactive on (b)(6) 2025 sid (b)(6) =repeat reactive /esa=nonreactive there was no reported impact to patient management.
Event or Problem Description
The customer reported in the month of (b)(6) 2025, there were 4 false repeat reactive results for alinity s chagas out of 3,131 specimens.Of these, 3 specimens were confirmed as nonreactive by enzyme strip assay (esa) confirmatory testing.The customer provided the following specimen sids for the repeat reactive results: on (b)(6) 2025, sid (b)(6) =repeat reactive /esa=nonreactive.On (b)(6) 2025, sid (b)(6) =repeat reactive /esa=nonreactive.On (b)(6) 2025, sid (b)(6) =repeat reactive /esa=nonreactive 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 chagas reagent, lot number 67249be00.Return testing was not completed as returns were not available.Review of tracking and trending for the alinity s chagas 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 67249be00.A review of field data for alinity s chagas ln 6p08-50 with regard to reactive rates and specifically (assuming zero prevalence), per month and for lot 67249be00 specifically was performed.The analysis included initial reactive rates (irr), repeat reactive rates (rrr) and specificity (assuming zero prevalence) at innovative blood resources inc (usa) peer sites and across a whole blood and plasma screening monitoring group.The performance of lot 67249be00 across a whole blood and plasma group and peer sites is 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 chagas reagent, lot number 67249be00.

• Brand Name: ALINITY S CHAGAS 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: 22386271
• Report Number: 3002809144-2025-00212
• Device Sequence Number: 7138275
• Product Code: QHM
• UDI-Device Identifier: 00380740117221
• UDI-Public: (01)00380740117221(17)250917(10)67249BE00
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: BL125689
• 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): 07/18/2025

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: 09/17/2025
• Device Catalogue Number: 06P08-50
• Device Lot Number: 67249BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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