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	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of complaint data for the products and complaint cause lots identified normal complaint activity for the complaint issue.The ticket trending review determined that there are no adverse trends.A review of labeling concluded that the issue is sufficiently addressed.The performance of the complaint cause lots was investigated by completing a review in the capa system for non-conformances, potential non-conformances and deviations.This review did not reveal any related non-conformances, potential non-conformances or deviations.A customer data review for alinity s chagas complaint lots was performed.Overall reactive rates across the account and at other us customer sites were collected and assessed.Overall reactive rates and specificity assuming zero prevalence across all customers using complaint lots are within product requirements.No product deficiency was identified.
Event or Problem Description
The account observed increased repeat reactive rates while using alinity s chagas (lots 16211be00, 23029be00, and 25291be00 and alinity s processing module serials (b)(4), serial (b)(4)).Supplemental esa testing performed identified multiple samples discrepant to alinity s chagas.There was no additional patient/donor information provided by the customer due to privacy issues.There was no reported impact to donor/patient management.The customer reported an increase in repeat reactive (rr) alinity s chagas results.The results provided were the following: on (b)(6) 2021 sid (b)(6) =2.03, 2.00, 1.99s/co (>/=1.00s/co = reactive) / confirmatory cesa = nonreactive.On (b)(6) sid (b)(6) = 2.14, 2.06, 2.00s/co / confirmatory cesa = indeterminate (grayzone).On (b)(6) sid (b)(6) =1.46, 1.03, 1.35s/co / confirmatory cesa = indt (grayzone).On (b)(6) sid (b)(6) = 1.29, 1.41, 1.44s/co / confirmatory cesa = indt (grayzone).On (b)(6) sid (b)(6) = 1.04, 1.02, 1.07s/co / confirmatory cesa = nonreactive.Early (b)(6) 2021 results are: (b)(6) sid (b)(6) = 2.05, 2.17, 2.16s/co / cesa confirmatory negative.On (b)(6) sid (b)(6) = 2.21, 2.31, 2.34s/co / cesa confirmatory negative.On (b)(6) sid (b)(6) = 1.28, 1.33, 1.38s/co / cesa confirmatory indeterminate.On (b)(6) sid (b)(6) = 7.89, 7.88, 7.38s/co (proficiency sample).On (b)(6) 2021 sid (b)(6) = 1.18 / retest on (b)(6) = 1.35 and 1.33s/co / cesa confirmatory negative.On (b)(6) 2021 the month of (b)(6) showed 5 rr samples.On (b)(6) sid (b)(6) rr (2.16, 2.17, 2.05 s/co) / confirmatory negative.On (b)(6) sid (b)(6) rr (2.34, 2.31, 2.21 s/co) / confirmatory = negative.On (b)(6) sid (b)(6) rr (1.38, 1.33, 1.28 s/co) / confirmatory indt.On (b)(6) sid (b)(6) rr (1.99, 1.63 s/co) / confirmatory indt.On (b)(6) sid (b)(6) rr (1.33, 1.35, 1.18 s/co) / confirmatory negative.On (b)(6) 2021 the month of (b)(6) showed 4 rr samples.On (b)(6) 2021 sid (b)(6) = 1.18, 1.17, 1.04s/co / cesa confirmatory positive.Sid (b)(6) = 1.36 and 1.53, 1.26s/co / confirmatory cesa indeterminate.On (b)(6) sid (b)(6) = 1.11, 1.14, 1,29s/co / confirmatory cesa negative.On (b)(6) 2021 sid (b)(6) =1.79 and 1.81s/co / confirmatory cesa negative.The account stated 5 samples were chagas repeat reactive in (b)(6) 2021.(b)(6) tested chagas reactive (1.22, 1.26, 1.05 s/co) but ceas confirmatory negative in (b)(6) 2021.(b)(6) tested chagas reactive (1.48, 1.88, 1.57 s/co) in (b)(6) 2021.(b)(6) tested chagas reactive (1.51 s/co) in (b)(6) 2021.(b)(6) tested chagas reactive (1.65, 1.50, 1.39 s/co in (b)(6) 2021.(b)(6) tested chagas reactive (1.53, 1.57, 1.56, 1.50 s/co) in (b)(6) 2021.

• 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: 12314398
• Report Number: 3002809144-2021-00483
• Device Sequence Number: 17144503
• 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
• Report Date (Section B): 08/12/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/12/2021
• 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: ALNTY S CHAGAS US 2500T, 06P08-50, 16211BE00; ALNTY S CHAGAS US 2500T, 06P08-50, 23029BE00; ALNTY S SYSTEM, 06P16-01, AS1240, AS1241