MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S HTLV I/II REAGENT KIT; HUMAN T-LYMPHOTROPIC VIRUS TYPES I AND II (E COLI, RECOM) AG AND SYNTH PEPTIDES

Catalog Number	06P07-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Completed information for patient identifier: sids (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false reactive alinity s htlv i/ii results for five cadaveric samples that were nat negative.The following data was provided: (b)(6) 2023; sid (b)(6) as1264 initial result = 1.43 s/co, repeats = 1.30 s/co and 1.14 s/co, nat = negative.(b)(6) 2023; sid (b)(6) as1264 initial result = 8.36 s/co, repeats = 16.24 s/co and 15.99 s/co, nat = negative.(b)(6) 2023; sid (b)(6) as1264 initial result = 3.66 s/co, repeats = 3.51 s/co and 1.24 s/co, nat = negative.(b)(6) 2023; sid (b)(6) as1264 initial result = 1.34 s/co, repeats = 1.20 s/co and 1.24 s/co, nat = negative.(b)(6) 2023; sid (b)(6) as1300 initial result = 2.18 s/co, repeats = 1.99 s/co and 2.08 s/co, nat = negative.The customer is unable to provide final tissue disposition.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false reactive alinity s htlv i/ii results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not performed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lots 46236be00 and the complaint issue.Labeling was reviewed and adequately addresses the issue under review.A technical review of field data for alinity s htlv i/ii was performed.Overall reactive rates of lot 46236be00 across bloodworks northwest (bwnw), usa, applicable peer sites and across a whole blood and plasma screening monitoring group were collected and assessed.Across the whole blood and plasma monitoring group the performance of lot 46236be00 is within product requirements and comparable to other lots analyzed in the comparison.At bloodworks northwest (bwnw), usa the specificity performance of lot 46236be00 is within package insert representative data for cadaveric specimens and greater than the specificity of peer sites.Based on the investigation alinity s htlv i/ii reagent lot 46236be00 is performing as intended, no systemic issue or deficiency of the alinity s htlv i/ii reagent was identified.
Event or Problem Description
The customer observed false reactive alinity s htlv i/ii results for five cadaveric samples that were nat negative.The following data was provided: 20mar2023 sid (b)(6) as1264 initial result = 1.43 s/co, repeats = 1.30 s/co and 1.14 s/co, nat = negative.18mar2023 sid (b)(6) as1264 initial result = 8.36 s/co, repeats = 16.24 s/co and 15.99 s/co, nat = negative.14mar2023 sid (b)(6) as1264 initial result = 3.66 s/co, repeats = 3.51 s/co and 1.24 s/co, nat = negative.12mar2023 sid (b)(6) as1264 initial result = 1.34 s/co, repeats = 1.20 s/co and 1.24 s/co, nat = negative, 31mar2023 sid (b)(6) as1300 initial result = 2.18 s/co, repeats = 1.99 s/co and 2.08 s/co, nat = negative.The customer is unable to provide final tissue disposition.No impact to patient management was reported.

• Brand Name: ALINITY S HTLV I/II REAGENT KIT
• Common Device Name: HUMAN T-LYMPHOTROPIC VIRUS TYPES I AND II (E COLI, RECOM) AG AND SYNTH PEPTIDES
• 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: 16885298
• Report Number: 3002809144-2023-00224
• Device Sequence Number: 6312670
• Product Code: QHM
• UDI-Device Identifier: 00380740117214
• UDI-Public: 00380740117214
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: BL 125675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023

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: 10/24/2023
• Device Catalogue Number: 06P07-60
• Device Lot Number: 46236BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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, AS1264; ALNTY S SYSTEM, 06P16-01, AS1264
• Patient Sex: Unknown