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 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation into this complaint included a customer data review / field service review, quality data review, and a complaint history review.The investigation is summarized as follows: customer data review / field service review: pipettor log file analysis revealed proper pipettor aspiration.The field service engineer (fse) during his visit performed a pipettor performance test script with passing result.The fse identified a faulty pipette tip inside the instrument and in the original box, noting that a faulty tip could be an explanation for the inconsistent sample pipetting.An independent investigation was performed on the faulty tips.Although no deficiency was identified, the supplier was notified of this first use failure on the part.A file attached to the complaint ticket shows a negative sars-cov-2 test result for a sample in question.Both negative and positive control results indicated no errors.Quality data review: a search of non-conformance and capa records was performed for instances related to false negative results received from samples that had not been aspirated on an alinity m system.The query did not find any records related to false negative results received from samples that had not been aspirated on an alinity m system.Complaint history review: a complaint search was performed to identify past complaint tickets for any instances of false negative results with the alinity m sars-cov-2 assay received from samples that had not been aspirated on an alinity m system.The complaint history review identified the ticket under investigation and one additional ticket related to false negative results with the alinity m sars-cov-2 assay received from samples that had not been aspirated on an alinity m system.The additional ticket was investigated and did not identify a product deficiency.Based on the results of the investigation, a product deficiency was not identified for the alinity m system (ln08n53-02).

Manufacturer Narrative

Elevated complaint investigation is in process.

Event Description

Customer is concerned about possible false negative results for the alinity m sars-cov-2 assay.The volume of pipetted samples is not the same for all samples and the results of these samples are displayed without pipetting errors.Customer reported that some samples have visibly no pipetted volume and no errors were displayed in the results.The absence of any signal of pipetting error is raising concern on the client that is afraid of having false negative results due to insufficient volume pipetted.Customer sent a list of some of the samples that raised the concern and the respective obtained results.It was noted there was no observation of actual false negative results obtained.It was also noted that some of the samples sent by the customer did flag with a pipetting error or an internal control (ic) error.Sample number first test result (abbott) second test result (abbott) complementary test: (b)(6).Follow up from the customer indicated that they observed an additional sample they believe wasn't pipetted.The customer reported that the volume was unchanged after sample aspiration.The instrument at the end of analysis gave a negative result without errors for the sample in question.The customer reloaded the same sample which was re-analyzed and displayed negative result.The samples where the customer was not sure about the pipetted volume were reprocessed.The results were not questioned by a physician.There is no known impact to patients.Complaint has been elevated for investigation.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.

• 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: joe hutson ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2243617619
• MDR Report Key: 10871099
• MDR Text Key: 252205780
• Report Number: 3005248192-2020-00110
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00884999048034
• UDI-Public: 00884999048034
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• 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
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1