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	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false reactive alinity s htlv i/ii results for two cadaveric tissue donors.The following data was provided (interpretation of results: <1.00 is nonreactive): on (b)(6) 2023, sid (b)(6), initial result = 5.24 s/co, repeats = 6.11 s/co and 6.57 s/co, additional laboratory data was provided: hiv ag/ab = 0.08 s/co, hbsag = 0.20 s/co, anti-hcv = 0.04 s/co, anti-hbc = 0.09 s/co, hemolysis result = 100 ng/dl.On (b)(6) 2023, sid (b)(6) initial result = 2.03 s/co, repeats = 1.64 s/co and 0.23 s/co, repeat with another lot number = 0.20 s/co, additional laboratory data was provided: hiv ag/ab = 0.06 s/co, hbsag = 0.35 s/co, anti-hcv = 0.02 s/co, anti-hbc = 0.10 s/co, hemolysis result = 20 ng/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
Completed information for section a1 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 two cadaveric tissue donors.The following data was provided (interpretation of results: <1.00 is nonreactive): (b)(6) 2023 sid (b)(6) initial result = 5.24 s/co, repeats = 6.11 s/co and 6.57 s/co.Additional laboratory data was provided: hiv ag/ab = 0.08 s/co, hbsag = 0.20 s/co, anti-hcv = 0.04 s/co, anti-hbc = 0.09 s/co, hemolysis result = 100 ng/dl.(b)(6) 2023 sid (b)(6) initial result = 2.03 s/co, repeats = 1.64 s/co and 0.23 s/co, repeat with another lot number = 0.20 s/co.Additional laboratory data was provided: hiv ag/ab = 0.06 s/co, hbsag = 0.35 s/co, anti-hcv = 0.02 s/co, anti-hbc = 0.10 s/co, hemolysis result = 20 ng/dl.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.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Evaluation of complaint data for the product and lot 49190be00 did not identify an increase in complaint activity for the complaint issue.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 lot 49190be00 and the complaint issue.Labeling was reviewed and adequately addresses the issue under review.A review of field data for alinity s htlv i/ii was performed.Overall reactive rates of lot 49190be00 at mid america transplant svc (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 49190be00 is within product requirements and comparable to other lots analyzed in the comparison.At mid america transplant svc (usa) the specificity performance of lot 49190be00 is within package insert representative data for cadaveric specimens.An analysis of specimen testing at the customer site confirmed the elevated values for sids (b)(6), while review of other testing at the site demonstrated consistent performance.A review of the customer-provided donor testing data was performed.The testing profile of sid (b)(6) demonstrates variable decreasing replicates across the initial and duplicate retests, with two reactive and one nonreactive result.The retest performed with another cartridge yielded a nonreactive result similar to that of the second retest replicate.This type of testing pattern may indicate an issue with sample integrity or incomplete clotting of the sample on test.A similar pattern was not observed in the data provided for sid (b)(6).However, further evaluation of false reactive results associated with cadaveric testing on the alinity s system was previously completed.This review determined that donor demographics (older age) and comorbidities, as well as sample integrity were identified as contributing factors for the false reactive results.Customer education to highlight the importance of pre-analytics to optimize sample integrity were carried out.Based on the investigation alinity s htlv i/ii reagent lot 49190be00 is performing as intended, no systemic issue or deficiency of the alinity s htlv i/ii reagent was identified.Section g1 has been updated to current contact information.Section d4 lot # was inadvertently reported as unknown and has been updated to 49190be00.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17766564
• Report Number: 3002809144-2023-00396
• Device Sequence Number: 17933457
• Product Code: QHM
• UDI-Device Identifier: 00380740117214
• UDI-Public: 00380740117214
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/24/2023

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: 03/05/2024
• Device Catalogue Number: 06P07-60
• Device Lot Number: 49190BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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) ; ALNTY S SYSTEM, 06P16-01, (B)(6)
• Patient Sex: Unknown