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	08/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The account generated repeat reactive alinity s chagas results on samples that repeated indeterminate or negative with confirmatory testing in (b)(6) 2021.Sid: (b)(6) tested confirmatory indeterminate.Sid: (b)(6) tested confirmatory indeterminate.Sid: (b)(6) tested confirmatory negative.Sid: (b)(6) tested confirmatory indeterminate.No specific donor information was provided.No impact to patient management was reported.
Event or Problem Description
Additional information was provided.September 2021 data showed alinity s chagas repeat reactive samples with confirmatory chagas (cesa) negative or indeterminate.Sid (b)(6) tested confirmatory negative.Sid (b)(6) tested confirmatory indeterminate.Sid (b)(6) tested confirmatory indeterminate.Sid (b)(6) tested confirmatory indeterminate.No specific donor information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Evaluation of complaint data for the product and likely cause lots identified normal complaint activity and the ticket trending review determined that there are no adverse trends.No additional issues identified.A review of labeling concluded that the issue is sufficiently addressed.The performance of the likely cause lots was investigated by completing a review in the capa system for non-conformances, potential non-conformances and deviations related to the likely cause lots.This review did not reveal any non-conformances, potential non-conformances or deviations.A customer data review for alinity s chagas reagent, ln 6p08-50, lots 25291be00 and 26408be00 was performed.The analysis included initial reactive rates, repeat reactive rates and specificity (assuming zero prevalence) at the account and us whole blood peer sites.The specificity and reactive rate performance of lots 25291be00 and 26408be00 at the account is within product requirements and comparable to the performance of the same lots at peer sites.Further, a review of the overall monthly reactive rates from 01/2021 to 10/2021 was performed.The review demonstrates that reactive rates were relatively higher in august 2021 as compared to june and july, however within the range of historical performance at the account and within product requirements as well as within the 95% confidence interval documented in the package insert.Based on this investigation, alinity s chagas reagent lots 25291be00 and 26408be00 are performing as expected.Based on the information within the complaint record, the devices met performance specifications and performed as intended at the customer site as the obtained reactive rates and specificity were within product requirements.Further, a systemic issue and/or product deficiency was not identified.
Event or Problem Description
Additional information was provided.October 2021 data showed repeat reactive alinity s chagas results on samples with confirmatory testing for sids (b)(6) was indeterminate.Confirmatory testing for sids (b)(6) was negative.No specific donor information was provided.No impact to patient management was reported.

• 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12595072
• Report Number: 3002809144-2021-00594
• Device Sequence Number: 11620817
• 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): 11/29/2021

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: 01/13/2022
• Device Catalogue Number: 06P08-50
• Device Lot Number: 25291BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 10/26/2021; 11/09/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/02/2021; 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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: ALINITY S CHAGAS LIST 6P08 LOT 24608BE00; ALNTY S CHAGAS US 2500T, 06P08-50, 26408BE00; ALNTY S SYSTEM, 06P16-01, AS1240; ALNTY S SYSTEM, 06P16-01, AS1240, AS1241; ALNTY S SYSTEM, 06P16-01, AS1240, AS1241
• Patient Sex: Unknown