MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S CHAGAS; TRYPANOSOMA CRUZI (E COLI, RECOMBINANT) ANTIGEN

Catalog Number 06P08-50

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2021

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 283759325
• Report Number: 3002809144-2021-00711
• Device Sequence Number: 1
• Product Code: QHM
• UDI-Device Identifier: 00380740117221
• UDI-Public: 00380740117221
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01,(B)(6)