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	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 patient identifier: complete list of sample id's are (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 increased reactive rates for alinity s chagas.The customer further reported there were samples that were repeat reactive and negative by other testing.The customer provided the following data: samples tested on lot 67249be00, a lot that was currently being used: sample id (b)(6) initial result was 1.84 (reactive) and repeat results were 1.69 (reactive) & 1.71 (reactive).Ortho esa testing generated a negative result.Sample id (b)(6) initial result was 1.98 (reactive) and repeat results were 1.99 (reactive) & 1.89 (reactive).Ortho esa testing generated a negative result.Sample id (b)(6) initial result was 1.11 (reactive) and repeat results were 1.40 (reactive) & 1.37 (reactive).Ortho esa testing generated a negative result.There was no reported impact to patient management.
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, and device history record review, and field data review.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.Device history review for the complaint lot did not identify any issues.Review of tracking and trending for the alinity s chagas reagent did not identify an increase in complaint activity related to the complaint issue.An increase in complaint activity was not identified for the complaint lot.The overall performance of the alinity s chagas reagent was reviewed using field data from customers.A review of field data for the overall performance of lot 67249be00 indicated the product was performing as expected.Labeling was reviewed and was found to address the customer reported issue.Based on the investigation, no systemic issue or deficiency of the alinity s chagas reagent, lot 67249be00 was identified.
Event or Problem Description
The customer observed increased reactive rates for alinity s chagas.The customer further reported there were samples that were repeat reactive and negative by other testing.The customer provided the following data: samples tested on lot 67249be00, a lot that was currently being used: sample id (b)(6) initial result was 1.84 (reactive) and repeat results were 1.69 (reactive) & 1.71 (reactive).Ortho esa testing generated a negative result.Sample id (b)(6) initial result was 1.98 (reactive) and repeat results were 1.99 (reactive) & 1.89 (reactive).Ortho esa testing generated a negative result.Sample id (b)(6)initial result was 1.11 (reactive) and repeat results were 1.40 (reactive) & 1.37 (reactive).Ortho esa testing generated a negative result.There was no reported impact to patient management.

• 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: 21793783
• Report Number: 3002809144-2025-00125
• Device Sequence Number: 8592830
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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): Initial
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 04/28/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY S SYSTEM, 06P16-01, AS1235; ALNTY S SYSTEM, 06P16-01, AS1235
• Patient Sex: Unknown