MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S CHAGAS; TRYPANOSOMA CRUZI (E COLI, RECOMBINANT) ANTIGEN

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	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no further information provided by the customer for donors.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 chagas results on multiple donor specimens which confirmed negative by esa confirmatory testing.The results provided were: jan2021 repeat reactive=4 / esa confirmatory testing negative=1.Mar2021 repeat reactive=2 /esa confirmatory testing negative =1.May2021 repeat reactive=3 / esa confirmatory testing negative=3.Jun2021 repeat reactive=3/ esa confirmatory testing negative=1.The alinity s processing module not in test of record before jan2021.Those data provided jul2020 through dec2020 for validation on alinity s processing module.There was no reported impact to patient management.
Additional Manufacturer Narrative
This submission being send for additional information provided on 25aug2021; section d10: new concomitant product: was updated to include alnty s processing modu, 06p16-01 as1248 and as1249.
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 16211be00.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.The customer data review for alinity s chagas reagent, lot number 16211be00 was performed.The analysis included initial reactive rates (irr), repeat reactive rates (rrr) and specificity (assuming zero prevalence) at innovative blood resources (ibr), us whole blood (wb) peer sites and across all us customer sites.The specificity and reactive rate performance of lot 16211be00 at ibr is comparable to the performance at peer sites and within product requirements.Further, the overall irr, rrr and specificity of lots 16211be00 across all us customer sites are within product requirements and accordant to the performance of all lots of the same assay evaluated in the comparison (irr: 0.000 to 0.112%; rrr: 0.000 to 0.110%; specificity: 99.890 to 100.000%).All data review indicating that the reagent performing as expected.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 16211be00.

• Brand Name: ALINITY S CHAGAS
• Common Device Name: TRYPANOSOMA CRUZI (E COLI, RECOMBINANT) ANTIGEN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12353483
• Report Number: 3002809144-2021-00502
• Device Sequence Number: 6014438
• Product Code: QHM
• UDI-Device Identifier: 00380740117221
• UDI-Public: 00380740117221
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 11/02/2021

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: 04/16/2021
• Device Catalogue Number: 06P08-50
• Device Lot Number: 16211BE00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 08/25/2021; 11/02/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/20/2021; 11/02/2021
• 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: (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6); AS1248, AS1249; ALNTY S SYSTEM, (B)(4)