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	11/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 stated that there are an increased number initial reactive alinity s chagas patient samples.The customer sent out samples to confirm and results are sometimes nonreactive or indeterminate.The customer provided the following data: sid: (b)(6), on (b)(6) 2022 initial result = 1.19 s/co reactive, on (b)(6) 2022 repeat results = 0.91 nonreactive and 1.11 reactive, confirmatory test(abbott esa) = nonreactive.Sid: (b)(6), on (b)(6) 2022 initial result = 1.15 s/co reactive, on (b)(6) 2022 repeat results = 1.34 reactive and 1.33 reactive, confirmatory test(abbott esa) = nonreactive.Sid: (b)(6), on (b)(6) 2022 initial result = 3.68 s/co reactive, on (b)(6) 2022 repeat results = 3.66 reactive and 3.70 reactive, confirmatory test(abbott esa) = nonreactive.Sid: (b)(6), on (b)(6) 2022 initial result = 1.12 s/co reactive, on (b)(6) 2022 repeat results = 1.12 reactive and 1.11 reactive, confirmatory test(abbott esa) = nonreactive.Sid: (b)(6), on (b)(6) 2022 initial result = 1.63 s/co reactive, on (b)(6) 2022 repeat results = 1.57 reactive and 1.73 reactive, confirmatory test(abbott esa) = indeterminate.Sid: (b)(6), on (b)(6) 2022 initial result = 1.03 s/co reactive, on (b)(6) 2022 repeat results = 1.05 reactive and 1.07 reactive, confirmatory test(abbott esa) = nonreactive.Sid: (b)(6), on (b)(6) 2022 initial result = 1.68 s/co reactive, on (b)(6) 2022 repeat results = 1.68 reactive and 1.79 reactive, confirmatory test(abbott esa) = indeterminate.The cutoff is 1.00 s/co.No adverse impact to donor or patient management was reported.
Event or Problem Description
The customer stated that there are an increased number initial reactive alinity s chagas patient samples.The customer sent out samples to confirm and results are sometimes nonreactive or indeterminate.The customer provided the following data: (b)(6).(b)(6) 2022 initial result = 1.19 s/co reactive.(b)(6) 2022 repeat results = 0.91 nonreactive and 1.11 reactive.Confirmatory test(abbott esa) = nonreactive.(b)(6).(b)(6) 2022 initial result = 1.15 s/co reactive.(b)(6) 2022 repeat results = 1.34 reactive and 1.33 reactive.Confirmatory test(abbott esa) = nonreactive.(b)(6).(b)(6) 2022 initial result = 3.68 s/co reactive.(b)(6) 2022 repeat results = 3.66 reactive and 3.70 reactive.Confirmatory test(abbott esa) = nonreactive.(b)(6).(b)(6) 2022 initial result = 1.12 s/co reactive.(b)(6) 2022 repeat results = 1.12 reactive and 1.11 reactive.Confirmatory test(abbott esa) = nonreactive.(b)(6).(b)(6) 2022 initial result = 1.63 s/co reactive.(b)(6) 2022 repeat results = 1.57 reactive and 1.73 reactive.Confirmatory test(abbott esa) = indeterminate.(b)(6).(b)(6) 2022 initial result = 1.03 s/co reactive.(b)(6) 2022 repeat results = 1.05 reactive and 1.07 reactive.Confirmatory test(abbott esa) = nonreactive.(b)(6).(b)(6) 2022 initial result = 1.68 s/co reactive.(b)(6) 2022 repeat results = 1.68 reactive and 1.79 reactive.Confirmatory test(abbott esa) = indeterminate.The cutoff is 1.00 s/co.Additional data provided on (b)(6) 2023: (b)(6) sample from (b)(6) 2022 initial results = repeat reactive confirmatory test(abbott esa) = reactive.(b)(6) sample from (b)(6) 2022 initial results = repeat reactive confirmatory test(abbott esa) = indeterminate.(b)(6) sample from (b)(6) 2022 initial results = repeat reactive confirmatory test(abbott esa) = indeterminate.(b)(6) sample from (b)(6) 2022 initial results = repeat reactive confirmatory test(abbott esa) = indeterminate.(b)(6) sample from (b)(6) 2022 initial results = repeat reactive confirmatory test(abbott esa) = negative.(b)(6) sample from (b)(6) 2022 initial results = repeat reactive confirmatory test(abbott esa) = negative.(b)(6) sample from (b)(6) 2022 initial results = repeat reactive confirmatory test(abbott esa) = negative no adverse impact to donor or patient management was reported.
Additional Manufacturer Narrative
Trending review determined no adverse trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.A customer data review for alinity s chagas reagent, lots 36321be00 and 40523be00 was performed.The analysis included initial reactive rates (irr), repeat reactive rates (rrr) and specificity (assuming zero prevalence) at (b)(6), across whole blood (wb) peer sites and all us customer sites using these lots.Aggregated performance of lots across all us customer sites (regardless of peer group) and selected wb peer sites is within product requirements and comparable to the performance of other lots of the same assay evaluated in the comparison.The chagas initial reactive rates (irr) and repeat reactive rates (rrr) for both lots 36321be00 and 40523be00 at obi are comparable to those of peer sites and both lots are performing as intended overall.The data review identified one site-specific observation in which chagas specificity increased after instrument maintenance was completed at obi (b)(6) 2022 and (b)(6) 2022 relative to the time period these lots were in use prior to this maintenance.Based on the investigation, alinity s chagas, ln (b)(6), lots 36321be00 and 40523be00 are performing as expected.Based on the information within the complaint record, the devices met performance specifications at the customer site as all reactive rates were within product requirements.Further, a systemic issue and/or product deficiency was not identified.Complete information for section a1 patient identifier:(b)(6).

• 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
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16023760
• Report Number: 3002809144-2022-00452
• Device Sequence Number: 6960200
• Product Code: QHM
• UDI-Device Identifier: 00380740117221
• UDI-Public: 00380740117221
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 02/10/2023

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: 06/22/2023
• Device Catalogue Number: 06P08-50
• Device Lot Number: 40523BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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