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	02/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that there are an increased number initial reactive alinity s chagas patient samples.One sample has come back indeterminate from confirmatory testing.The customer has provided the following data: (b)(6) results from (b)(6) 2023 = 2.15 repeated on (b)(6) 2023 results = 1.91 and 2.17 confirmatory indeterminate; (b)(6) results from (b)(6) 2023 = 1.15 repeated on (b)(6) 2023 results = 1.22 and 1.27 confirmatory test indeterminate; (b)(6) results from (b)(6) 2023 = 1.61 repeated on (b)(6) 2023 results = 1.57 and 1.59 confirmatory test negative; (b)(6) results from 17feb2023 = 2.28 repeated on (b)(6) 2023 results = 2.38 and 2.18; (b)(6) results from 23feb2023 = 1.01 repeated on (b)(6) 2023 results = 1.05 and 1.06.No adverse impact to donor or patient management was reported.
Additional Manufacturer Narrative
Complete information for patient identifier: sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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 technical review of field data for alinity s chagas reagent, lot 40523be00 was performed.The analysis included initial reactive rates (irr), repeat reactive rates (rrr) and specificity (assuming zero prevalence) across obi, applicable peer sites and across all us customer sites were collected and assessed.Aggregated performance of lot 40523be00 across all us customer sites (regardless of peer group) are within product requirements and comparable to the performance of other lots of the same assay evaluated in the comparison.Additionally, a review of the overall monthly reactive rates from august 2022 to february 2023 was performed.Review of the time-based (monthly) data demonstrates that the performance of the customer of interest is comparable or better to the performance of their peers.The performance of the assay across all months is within product requirements.Based on the investigation, no deficiency for lot number 40523be00 was identified.
Event or Problem Description
The customer stated that there are an increased number initial reactive alinity s chagas patient samples.One sample has come back indeterminate from confirmatory testing.The customer has provided the following data: (b)(6) results from 04feb2023 = 2.15 repeated on 05feb2023 results = 1.91 and 2.17 confirmatory indeterminate.(b)(6) results from 10feb2023 = 1.15 repeated on 11feb2023 results = 1.22 and 1.27 confirmatory test indeterminate.(b)(6) results from 13feb2023 = 1.61 repeated on 15feb2023 results = 1.57 and 1.59 confirmatory test negative.(b)(6) results from 17feb2023 = 2.28 repeated on 19feb2023 results = 2.38 and 2.18 confirmatory test indeterminate.(b)(6) results from 23feb2023 = 1.01 repeated on 24feb2023 results = 1.05 and 1.06 confirmatory test indeterminate.Additional data provided 16mar2024: (b)(6) results from 03mar2023 = 1.40 repeated on 05mar2023 results = 1.50 and 1.54.(b)(6) results from 08mar2023 = 1.03 repeated on 10mar2023 results = 1.03 and 1.00.(b)(6) results from 09mar2023 = 1.74 repeated on 10mar2023 results = 1.65 and 1.62.(b)(6) results from 14mar2023 = 1.37 repeated on 14mar2023 results = 1.45 and 1.41.No adverse impact to donor or patient management was reported.
Additional Manufacturer Narrative
Additional patient testing added to section b5: describe event or problem.Complete information for section a1 patient identifier: sid (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: 16483459
• Report Number: 3002809144-2023-00104
• Device Sequence Number: 5263417
• 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,Followup
• Report Date (Section B): 04/20/2023

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: 02/14/2023
• Supplement Date Received by Manufacturer: 03/16/2023; 04/18/2023
• Initial Report FDA Received Date: 03/04/2023
• Supplement Report FDA Received Date: 04/04/2023; 04/20/2023
• 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) ; ALNTY S SYSTEM, 06P16-01, (B)(6)
• Patient Sex: Unknown