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 12/07/2023

Event Type  malfunction  

Event Description

The customer reported 5 false not detected results on the alinity m hr hpv amp kit.The customer reported that results for the alinity m hr hpv amp kit are erratic for "other b" making proper analysis impossible.Five sids (sample ids) were provided.Two samples received error codes when tested.The sids in question were tested on 12/07/2023 on alinity m sn (serial number (b)(6).Two samples produced error codes (ec) 1991 (error regarding fluorescence signal evaluation) and 1987 (error regarding inability to process results due to abnormal signal).The remaining three samples (were processed without error.Signal for hpv "other b" was not detected by the system for all five samples.Inspection of pcr curves shows non-sigmoidal and erratic behavior for "other b' signal.The customer suspects these are false not detected (false negative) results.All samples in question were retested on 12/11/2023 without error.All samples gave "not detected" results.The customer reported 4 of the sids as negative.One sid was released as positive for "other b" due to the rise of "other b" target around cycle 30 of the retest.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: 3005248192-2023-00323, with suspect product alinity m hr hpv amplification reagent kit list number 09n15-090 lot number 385721.

Manufacturer Narrative

This event is no longer reportable against the alinity m system, list number 08n53-002.See mdr 3005248192-2023-00323 for investigation of alinity m hr hpv amp kit (list 09n15-090) lot 385721 for this incident.

Manufacturer Narrative

Corrections updated d4 udi from (b)(4).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 and was not investigated.See mdr 3005248192-2023-00323 for investigation of alinity m hr hpv amp kit (list 09n15-090) lot 385721 for this incident.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 runs which involved the discrepant results were valid and 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: 18369076
• MDR Text Key: 331338110
• Report Number: 3005248192-2023-00324
• Device Sequence Number: 1
• Product Code: OOI
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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
• Date Manufacturer Received: 03/21/2024
• 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