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	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that in the month of (b)(6) 2022, there were 4 reactive alinity s chagas patient samples that were negative using the esa chagas method.When the customer encounters a reactive result on the alinity s processing module, they automatically repeat the sample again in duplicate and if it remains reactive, then they send it out for confirmation using the esa chagas method.The customer indicated that of 13 repeatedly reactive alinity s chagas samples that were sent out for confirmation, 4 of those were reported as confirmation negative (esa method).No adverse impact to donor or patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient/donor information was included.Additional patient/donor details are not available.
Additional Manufacturer Narrative
Trending review determined no adverse trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.A customer data review for alinity s chagas reagent, lot 26408be00 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.Aggregated performance of lot 26408be00 across all us customer sites (regardless of peer group) and selected wb peer sites is within product requirements and comparable to the performance of other lots of the same assay evaluated in the comparison.Additionally, a review of the overall monthly reactive rates from october 2021 to march 2022 was performed.The review demonstrates that reactive rates in january 2022 at ribc is within the range of historical performance.The performance of the assay across all months is within product requirements.Based on the investigation, no deficiency for lot number 26408be00 was identified.
Additional Manufacturer Narrative
Upon review on september 12, 2022, it was discovered that additional associated devices were omitted on the previous submission and have been added to this 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 N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14021806
• Report Number: 3002809144-2022-00119
• Device Sequence Number: 11421328
• 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,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: 02/16/2022
• Device Catalogue Number: 06P08-50
• Device Lot Number: 26408BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 06/09/2022; 09/12/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 06/10/2022; 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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, AS1215; ALNTY S SYSTEM, 06P16-01, AS1215; ALNTY S SYSTEM, 06P16-01, AS1215; ALNTY S SYSTEM, 06P16-01, AS1233; ALNTY S SYSTEM, 06P16-01, AS1234
• Patient Sex: Unknown