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 06P07-55

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2022

Event Type  malfunction  

Event Description

The customer observed false reactive alinity s htlv i/ii results for one donor.The following data was provided (>/=1.00 s/co is reactive): sample id (b)(6) initial result, on (b)(6) 2022, was 14.52, repeats were 15.00 and 14.14 s/co.There was no impact to donor management reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 06p07-55, that has a similar product distributed in the us, list number 06p07-60.

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, device history record review, and field data review.Trending review determined no related trend for the issue and the product.Return testing was not completed as returns were not required.Device history record review did not identify any non-conformances or deviations with the likely cause lot number and complaint issue.To assess field performance, initial reactive rates, repeat reactive rates and specificity (assuming 0 prevalence) for the lot number were calculated.The performance of the identified reagent lot of the assay at the customer of interest were consistent with the performance of the other lots tested at the site and aligned with the performance of the peer group.(b)(4).Summary, the field data analysis for the complaint lot of alinity s htlv-i/htlv-ii, list number 06p07-55 at ibts did not identify issues associated with initial reactive, repeat reactive rate, initial-repeat reactive rate or specificity (based on assumption of zero prevalence).Additionally, reactive rate field performance data was evaluated to determine how many samples within the timeframe are exhibiting reactivity on the htlv assay at ibts and other customer sites.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of the alinity s htlv-i/ii, lot number 43298be00, was identified.

• Brand Name: ALINITY S HTLV I/II REAGENT KIT
• Type of Device: 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: 16070207
• MDR Text Key: 308532329
• Report Number: 3002809144-2022-00457
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2023
• Device Catalogue Number: 06P07-55
• Device Lot Number: 43298BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6)