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 11/14/2023

Event Type  malfunction  

Event Description

The customer reported 1 false not detected result while using the alinity m high risk (hr) hpv assay on the alinity m system.The customer reported that they tested sample id (sid) (b)(6) three times with the alinity m hr hpv assay on their alinity m system.The customer reported that they had been observing non-sigmoidal amplification curves on their hpv assay and were therefore checking every result and retesting the samples that they found to have abnormal amplification curves.The first result was generated on (b)(6) 2023 and the result was "not detected." the second result was generated on (b)(6) 2023 and the result again was "not detected." the third result was generated on (b)(6) 2023 and the result was detected for the "other hr hpv b" genotype.Sample id test date alinity m hr hpv test result: (b)(6) (b)(6) 2023 not detected.(b)(6) (b)(6) 2023 not detected.(b)(6) (b)(6) 2023 other hr hpv b.There was no report of impact to patient management.

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.The following additional mdr has also been submitted with the following suspect product: 3005248192-2023-00301, with suspect product alinity m hr hpv amplification reagent kit list number 09n15-090 lot number 384923.

Manufacturer Narrative

Corrected h6.This event is no longer reportable against the alinity m system, list number 08n53-002.See mdr 3005248192-2023-00301 for investigation of alinity m hr hpv amp kit (list 09n15-090) lot 384923 for this incident.

Manufacturer Narrative

Correct h4 from 19-jun-2020 to 13-dec-2022.

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 384923 for this incident and was not investigated.See mdr 3005248192-2023-00301 for investigation of alinity m hr hpv amp kit (list 09n15-090) lot 384923 for this incident.Investigation into this complaint included a customer data review, retain / file sample evaluation, a quality data review, and a complaint history review.Investigation is summarized as follows: customer data review: customer result log files were reviewed.The runs were valid.The amplification curves for the reported false negative samples showed non-sigmoidal amplification.The frequency of occurrence of the abnormal curves was calculated to assess the performance of the product in the field.A product deficiency could not be identified from this analysis.Additionally, results from the alinity m hr hpv assay should be interpreted in conjunction with other clinical and laboratory findings.If the hpv results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.There is no indication that the alinity m hr hpv amp kit (list 09n15-090) lot 384923 is performing outside of established design performance specifications based on the elements reviewed in this section.Retain/file sample review: file sample testing was performed.All sample types tested generated correct results (negative samples/controls were not detected, and positive samples/controls generated expected calls).A product deficiency could not be identified by the file sample evaluation for the alinity m hr hpv assay (list 09n15-090) lot 384923.The assay reagents performed as expected and met the assay specification requirements without any error/message codes or performance related flags on the run controls.All replicates passed with no error codes presented, no instances of false negatives, and no signs of abnormal curves.Quality data review: device history record / batch record review: review of the manufacturing packets for alinity m hr hpv amp kit (list 09n15-090) lot 384923 (including the components) did not identify any issues which could result in the reported complaint.Additionally, the quality control (qc) testing for the alinity m hr hpv amp kit (list 09n15-090) lot 384923 (including the components) met all validity and acceptance criteria.No issues related to the reported complaint were reported during qc testing.Capa / non-conformance review: a capa lot search was performed to identify any existing internal quality records which could result in the reported complaint during production or internal use.No existing internal quality records related to the reported complaint were identified as a result of this review for the reported lot.Complaint history review: a complaint review was performed to identify any similar complaints to the ticket being investigated for alinity m hr hpv amp kit (list 09n15-090) lot 384923.Complaint trending was performed and did not identify a trend violation.A product deficiency was not identified by this evaluation.Based on the results of the investigation elements, a product deficiency for the alinity m hr hpv amp kit (list 09n15-90) lot 384923 was not identified.

• Brand Name: ALINITY M SYSTEM
• Type of Device: REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315
• MDR Report Key: 18265503
• MDR Text Key: 329716745
• Report Number: 3005248192-2023-00302
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/25/2024

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 Catalogue Number: 08N53-002
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 01/11/2024; 01/31/2024; 03/21/2024
• Supplement Dates FDA Received: 01/30/2024; 01/31/2024; 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1