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

Model Number 08N53-002

Device Problem False Negative Result (1225)

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

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

Elevated complaint investigation will be performed.

Event Description

Customer called reporting an aspiration issue on some sample tubes when running the alinity m sars-cov-2 assay on their alinity m system.On (b)(6) 2020, customer observed that samples tubes were not aspirated.The volume (1 ml) before the run is the same after the run.The instrument didn´t give any error code.Customer is concerned because all tubes not aspirated were reported as negatives, which could lead to false negative results.Customer confirmed that in sars-cov-2 protocol they always put 1ml of patient sample.Customer was advised to check patient sample tubes to see if there were any bubble, and repeat the tube in question.All samples were repeated the same day, aspirated correctly and generated negative results.There was no impact to patient management as the samples all repeated as negative.Field service engineer (fse) completed a file analysis.Based on log review, samples appear to have been properly aspirated by the instrument.Evaluation will be written as a worst case false negative sars-cov-2 result.This incident is being reported to fda because the incident occurred in (b)(6) using the alinity m system, list 8n53-02, which is also us fda approved.

Manufacturer Narrative

Investigation into this complaint included a customer data review, a nonconformance/ capa history review and a complaint history review.The investigation is summarized as follows: log file analysis revealed proper pipettor aspiration.Samples were repeated the same day and reported the same test results as negatives.The nonconformance/capa (corrective and preventative action) search did not find any records related to false negative results received from samples that had not been aspirated on an alinity m system.The complaint history review found 1 additional complaint ticket related to false negative results received from samples that had not been aspirated on an alinity m system.Based on the results of the investigation, a product deficiency was not identified for the alinity m system (ln 08n53-02).

• 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
• MDR Report Key: 10731854
• MDR Text Key: 213001696
• Report Number: 3005248192-2020-00083
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00884999048034
• UDI-Public: 00884999048034
• Combination Product (y/n): N
• PMA/PMN Number: P190025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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: No Information
• Device Model Number: 08N53-002
• Device Catalogue Number: 08N53-02
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/24/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1