MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ALINITY M SYSTEM; REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM

Catalog Number 08N53-002

Device Problem False Negative Result (1225)

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

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

Elevated complaint investigation will be initiated.This incident is being reported to fda because the incident occurred in poland using the alinity m system, list 08n53-002, which is also us fda approved.

Event Description

The customer reported a discrepant result on the alinity m hr hpv amp kit between two alinity m systems.Sid (sample id) (b)(6) was processed on alinity m sn (serial number) (b)(6) on (b)(6) 2024 with result "not detected".Visual inspection of the curves shows presence of a strong "other a" signal that was not accepted by the software.The sample was re-tested on alinity m sn (b)(6) on (b)(6) 2024 with result "not detected".Visual inspection of curves shows no signal apart from cellular control (cc).The sample was re-tested again on alinity m sn (b)(6) on (b)(6) 2024 with result "other a" detected.There was no report of impact to patient management.

Manufacturer Narrative

Likely cause within the complaint ticket was updated from alinity m system, list number 08n53-002 to alinity m hr hpv amp kit (list 09n15-090) lot 385721 for this incident.Corrections: corrected d1 from alinity m system to alinity m hr hpv amp kit.Correctred d2 from real time nucleic acid amplification system to kit, dna detection, human papillomavirus.Corrected d4 catalog number from 08n53-002 to 09n15-090.Added d4 lot number 385721.Corrected d4 udi from (b)(4).Removed d4 serial number.Added d4 expiration date 21-feb-2025.Corrected h4 manufacture date from 13-dec-2022 to 22-may-2023.Investigation into this complaint included a customer data review, a quality data review and a complaint history review.Investigation is summarized as follows: retain sample evaluation.The file sample testing did not identify a product deficiency for the alinity m hr hpv amp kit (list 09n15-090) lot 385721.Customer data review: customer result log files were reviewed.The run which involved the discrepant result were valid and met assay specification requirements.The validity of the run met assay specification requirements.A product deficiency could not be identified from this analysis.Quality data review: device history record / batch record review: the device history records (dhr) review for alinity m hr hpv amp kit (list 09n15-090) lot 385721 (including the components) was performed.The manufacturing packets were reviewed to identify any issues related to the reported complaint during production of the lot components.No issues were identified.No issues were found during quality control (qc) testing.The products passed quality specifications at the time of release.Capa / non-conformance review: the capa review for alinity m hr hpv amp kit (list 09n15-090) lot 385721 (including the components) was performed to identify any records that were potentially related to the reported complaint.The search did not identify any records related to the reported issue for this lot number.Complaint history review: a lot specific complaint history review was performed to identify any similar complaints to the ticket being investigated, which reported discrepant results while using alinity m hr hpv amp kit (list 09n15-090) lot 385721.A trend violation for list 09n15 was not identified.A product deficiency was not identified by this evaluation.Based on the results of the investigation elements, a product deficiency alinity m hr hpv amp kit (list 09n15-090) lot 385721 was not identified.

• Brand Name: ALINITY M SYSTEM
• Type of Device: REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 east touhy ave.; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 east touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: albert chianello ; 1300 east touhy ave.; des plaines, IL 60018-3315 ; 2242064064
• MDR Report Key: 18552251
• MDR Text Key: 333357468
• Report Number: 3005248192-2024-00009
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00884999048034
• UDI-Public: (01)00884999048034(11)221213(240)08N53-002
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P190025
• 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: 03/18/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08N53-002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1