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

Model Number 08N53-002

Device Problems False Negative Result (1225); Volume Accuracy Problem (1675)

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

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

An elevated complaint investigation will be performed; a follow-up report will be submitted once the investigation is complete.

Event Description

While running alinity m hiv-1 assay, the customer is visually checking the fill volume inside the sample tubes after testing as they suspect that the pipettor does not aspirate the samples correctly.The instrument is not showing any error, but reports the sid (b)(6) fill volume after testing appeared the same as prior to testing and the pierceable cap is pierced.As the sample appears to not be aspirated, the customer reran the sample.On site, the fse (field service engineer) checked the racks for missing spring clips which would affect the liquid level detection (lld) / aspiration of the sample and noticed that they seemed "worn".The damaged racks were in clip locations that did not correspond to the sample in question and the racks were quarantined and discarded.The fse performed troubleshooting and the lld, aspiration and dispense checks all passed.On (b)(6) 2023, the instrument produced valid positive results for test specimens sids (b)(6) (1554 copies/ml) and (b)(6) (1950 copies/ml).The remaining fill volume for each of these samples was approximately 630 ul from an input of 1000 ul.The results for these two samples are lower than the average of 3060 copies/ml for other samples tested on the rack.The sample in position 2 (sid (b)(6)) was not associated with an instrument error and produced a valid positive result of 1754 copies/ml which is lower the average of 3985 copies/ml tested on the rack.The remaining volume for this sample was approximately 630ul from an input of 1000ul.The customer was advised to uncap the transport tubes before loading into the instrument as per latest package insert.

Manufacturer Narrative

Corrections: updated d4 with correct field chosen as serial number 333.

Manufacturer Narrative

Updates: b5: added information regarding hiv-1 assay false negative result which was potentially caused by aspiration errors.Event was deemed reportable based on the observation of these false negative results.Corrections: updated h6 with coding for false negative results.

Event Description

The customer reported a false negative result on the alinity m hiv-1 assay.Sample id (sid) (b)(6) was negative when run on (b)(6) 2023 and positive in the second run repeated that same day.A new sample was taken from the original tube and run on the system on (b)(6) 2023 under test id (b)(6).The result was positive with a viral load of 530 copies/ml the original tube was reran on (b)(6) 2023 under test id (b)(6) and resulted as positive with a viral load of 508 copies/ml.The false negative result was not reported outside of the laboratory.There was no known impact to patient management.While running alinity m hiv-1 assay, the customer is visually checking the fill volume inside the sample tubes after testing as they suspect that the pipettor does not aspirate the samples correctly.The instrument is not showing any error, but reports the sid (b)(6) fill volume after testing appeared the same as prior to testing and the pierceable cap is pierced.As the sample appears to not be aspirated, the customer reran the sample.The customer was advised to uncap the transport tubes before loading into the instrument as per latest package insert.

Manufacturer Narrative

Investigation into this complaint included a customer data review, a quality data review and a complaint history review.Customer data review the validity of the runs containing the discrepant result was verified.The assay met specification requirements and no error codes or flags were displayed for the run controls.Amplification curves appeared normal and showed normal amplification for the hiv-1 target as well as for the internal control.Per the package insert, the results from the alinity m hiv-1 assay must be interpreted within the context of all relevant clinical and laboratory findings.If the hiv-1 results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.Quality data review device history record / batch record review: review of the batch records did not identify any existing internal quality records which could result in the reported complaint during production or internal use.The caps passed iqc (internal quality control) which includes screening for uniformity of color, flashing, short shots, defects in the foil layer or blue membrane contaminants, any molding imperfections.Qc checks performed for the product consist of verifying that the correct part numbers of each component are being used and verifying the calibration of the weight counting scales being used to ensure that the counts are correct.No quality issues were found after all the qc check was performed capa review: a capa review 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.Complaint history review: a complaint history review was performed to identify any similar complaints to the ticket being investigated.A product deficiency was not identified by this evaluation.Based on the results of the investigation elements a product deficiency 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: 16312383
• MDR Text Key: 309529661
• Report Number: 3005248192-2023-00096
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00884999048034
• UDI-Public: 00884999048034
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/24/2023

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 Model Number: 08N53-002
• Device Catalogue Number: 08N53-02
• Device Lot Number: 333
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 01/13/2023; 01/13/2023; 04/21/2023
• Supplement Dates FDA Received: 02/07/2023; 03/21/2023; 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1