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	09/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed false repeat reactive alinity s htlv i/ii results on a cadaveric tissue donor sample.The following data was provided: 11sep2022 sample id (b)(6) initial result = 2.55; repeat = 3.39 and 3.76 s/co.Western blot = negative.The donated tissue was discarded due to the false reactive htlv i/ii results.The sample appearance was normal and spun according to the package insert requirements.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, review of field data, returned sample analysis, and a cross functional team (cft) review.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket and trending review determined no trends for the complaint list number/lot number or complaint issue.Device history record review did not identify any potential non-conformances, non-conformances or deviations with the complaint lot.To assess the level of hemolysis, a visual inspection of the returned cadaveric samples was performed.The assessment was performed by applying the visual inspection reference guide of the american red cross biomedical services.Per american and european red cross standards, the acceptable level of hemolysis (based on visual/qualitative inspection) is less than 0.8%.The following summarizes the findings of the visual inspection of the returned samples: 171581: 2% of hemolysis; 171511: 0.9% of hemolysis; 171268: 1% of hemolysis; 171649: 0.9% of hemolysis; 172614: 1% of hemolysis.The assessment concluded all 5 samples exceed the acceptable level of hemolysis per the american and european red cross standards.Further, alinity s htlv i/ii testing and cell-dyn sapphire hemoglobin testing on the returned specimens was performed.The testing concluded all 5 samples were nonreactive and none had hemoglobin levels exceeding package insert (all 5 less than 500 mg/dl).A technical review of field data for alinity s htlv i/ii was performed.Overall, the reactive rates of reagent lot 34143be00 across core, applicable peer sites and across all us customer sites were collected and assessed.Across all us customers, the initial reactive rate (irr), repeat reactive rate (rrr) and specificity (assuming zero prevalence) observed for lot 34143be00 is within product requirements, within package insert representative data for cadaveric specimens and comparable to other lots analyzed in the comparison.Lot 34143be00 was not tested at peer sites.The cft reviewed and determined the adverse event was related to correct use and concluded the risk management file (rmf) is adequate and sufficiently addresses the issue under review.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation the alinity s htlv i/ii reagent lot 34143be00 met performance specifications and performed as intended at the customer site as all reactive rates were within product requirements respectively package insert claims for cadaveric testing.Further, a systemic issue and/or product deficiency was not identified.

• 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: 15506685
• Report Number: 3002809144-2022-00339
• Device Sequence Number: 5920475
• Product Code: QHM
• UDI-Device Identifier: 00380740117214
• UDI-Public: 00380740117214
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2023
• Device Catalogue Number: 06P07-60
• Device Lot Number: 34143BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• 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, (B)(6) ; ALNTY S SYSTEM, 06P16-01, (B)(6)
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown