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	11/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer questioned repeatedly reactive alinity s chagas results for five patients.The following data was provided: (b)(6) 2021 sid (b)(6) initial result (b)(6) s/co (reactive), repeated (b)(6) 2021 result (b)(6) s/co (reactive) and (b)(6) s/co (reactive; final assay interpretation repeatedly reactive) repeat confirmation runs using another method (unknown) pending.(b)(6) 2021 sid (b)(6) initial result (b)(6) s/co (reactive), repeated (b)(6) 2021 result (b)(6) s/co (reactive) and (b)(6) s/co (reactive; final assay interpretation repeatedly reactive) repeat confirmation runs using another method (unknown) negative.(b)(6) 2021 sid (b)(6) initial result (b)(6) s/co (reactive), repeated (b)(6) 2021 result (b)(6) s/co (reactive), repeated (b)(6) s/co (reactive; final assay interpretation repeatedly reactive) repeat confirmation runs using another method (unknown) pending.(b)(6) 2021 sid (b)(6) initial result (b)(6) s/co (reactive), repeated (b)(6) 2021 result (b)(6) s/co (reactive) and (b)(6) s/co (reactive; final assay interpretation repeatedly reactive) repeat confirmation runs using another method (unknown) positive.(b)(6) 2021 sid (b)(6) initial result (b)(6) s/co (reactive), repeated (b)(6) 2021 result (b)(6) s/co (reactive) and (b)(6) 2021 result (b)(6) s/co (reactive; final assay interpretation repeatedly reactive) repeat confirmation runs using another method (unknown) positive.It is unknown what the customer believes the correct result is for each patient.No impact to patient management was reported.
Additional Manufacturer Narrative
Multiple patients were involved in this event.No patient demographic information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
An investigation was performed for false reactive results while using alinity s chagas, list number (ln) 6p08-50, lot 27175be00.A review of tickets was performed and identified normal complaint activity.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Review of field data was performed; the analysis included initial reactive rates (irr), repeat reactive rates (rrr) and specificity (assuming zero prevalence) at oklahoma blood institute (obi), whole blood (wb) peer sites and across all customer sites using this lot.The specificity and reactive rate performance of lot 27175be00 at obi is within product requirements and comparable to the performance at peer sites.Further, aggregated performance of lot 27175be00 across all customer sites using this lot is within product requirements and comparable to the performance of other lots of the same assay.Performance of lot 27175be00: obi: irr: 0.072%; rrr: 0.072%; specificity: 99.928% peer sites (excluding obi): irr: 0.084%; rrr: 0.084%; specificity: 99.916% all customer sites: irr: 0.090%; rrr: 0.090%; specificity: 99.910% a review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the alinity s chagas, list number (ln) 6p08-50, lot 27175be00 was identified.Section g has been updated to reflect personnel changes that have occurred subsequent to the initial submission.

• 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, IL N39 E-932 ; 2246682940
• MDR Report Key: 13056283
• Report Number: 3002809144-2021-00711
• Device Sequence Number: 13829543
• 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): 03/01/2022

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 Expiration Date: 03/08/2022
• Device Catalogue Number: 06P08-50
• Device Lot Number: 27175BE00
• 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: 12/03/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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: ALNTY S SYSTEM, 06P16-01,(B)(6)
• Patient Sex: Unknown