MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT PRISM CHAGAS ASSAY KIT; TRYPANOSOMA CRUZI (E COLI, RECOMBINANT) ANTIGEN

Catalog Number	07K35-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of complaint data for the product and likely cause abbott prism chagas identified normal complaint activity.In-house evaluation of returned donor samples on abbott esa chagas resulted nonreactive for samples chagas pos 05, chagas pos 08, chagas pos 17 and chagas pos 18.As the lot numbers are unknown, the performance of the likely cause list number (7k35-68) was investigated by completing a review for non-conformances, potential non-conformance and deviations.This review did not identify any non-conformances, potential non-conformances or deviations for the list number.Manufacturing documentation for the likely cause did not identify any issues associated with the complaint issue.A review of overall customer field data was performed regarding initial reactive rate (irr), repeat reactive rate (rrr) and specificity for list number 7k35-68.The irr, the rrr and the specificity of the list number is within package insert specifications.A review of labeling concluded that the issue is sufficiently addressed.No systemic issue or product deficiency was identified.
Event or Problem Description
Archived customer samples were returned and evaluated in-house by abbott on esa chagas.Samples chagas pos 05, chagas pos 08, chagas pos 17, and chagas pos 18 were confirmed to be nonreactive.Therefore, test results obtained on prism chagas for these two samples are considered false reactive.No impact to patient management was reported.

• Brand Name: ABBOTT PRISM CHAGAS ASSAY KIT
• Common Device Name: TRYPANOSOMA CRUZI (E COLI, RECOMBINANT) ANTIGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; 433331157
• MDR Report Key: 13567520
• Report Number: 1415939-2022-00009
• Device Sequence Number: 5913408
• Product Code: QHM
• UDI-Device Identifier: 00380740062941
• UDI-Public: 00380740062941
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 02/21/2022

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 Catalogue Number: 07K35-68
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: PRSM NEXT RFRB IN, 06A36-11, 1163-96
• Patient Sex: Unknown