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	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false repeat reactive alinity s chagas results on multiple donor specimens which confirmed negative by esa confirmatory testing in two different sites ribc and nybc.The customer provided a summary of results across several months and lot numbers.No individual donor results were provided.The number of false repeat reactive donors for each month were: ribc: may2022 repeat reactive=2 / esa confirmatory testing negative=2 nybc: feb2022 repeat reactive=4 / esa confirmatory testing negative=4 apr2022 repeat reactive=2 / esa confirmatory testing negative=2 may2022 repeat reactive=1 / esa confirmatory testing negative=1 there was no reported impact to donor/patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, field data history of alinity s chagas reagent, lot number 33106be00.The ticket search determined that there is normal complaint activity for the likely cause lot.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.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.The customer data review for alinity s chagas reagent, lot number 33106be00 was performed.The analysis included initial reactive rates (irr), repeat reactive rates (rrr) and specificity (assuming zero prevalence) at rhode island blood center (ribc), across whole blood (wb) peer sites and all us customer sites using this lot.A aggregated performance of lot 33106be00 across all customer sites and wb peer sites is within product requirements and comparable to the performance of other lots of the same assay evaluated in the comparison.The reactive rates of lots 33106be00 at ribc were within product requirements and comparable to the performance at the peer sites as well as to other lots in the field.All data review indicating that the reagent performing as expected.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity s chagas reagent, lot number 33106be00.

• 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: 15396187
• Report Number: 3002809144-2022-00322
• Device Sequence Number: 6102604
• Product Code: QHM
• UDI-Device Identifier: 00380740117221
• UDI-Public: 00380740117221
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 09/27/2022

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: 10/31/2022
• Device Catalogue Number: 06P08-50
• Device Lot Number: 33106BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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
• Usage of Device: Unknown
• 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) ; ALNTY S SYSTEM, 06P16-01, (B)(6) ; ALNTY S SYSTEM, 06P16-01, (B)(6) ; ALNTY S SYSTEM, 06P16-01, (B)(6)
• Patient Sex: Unknown