MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ALINITY M EBV AMP KIT; NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF EPSTEIN-BARR VIRUS (EBV)

Catalog Number 09N43-095

Device Problem Low Test Results (2458)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

The customer reported a misquantified low result on the alinity m ebv amp kit.Sid (sample id) (b)(6) was tested three times: first result ( on (b)(6) 2024): about 700iu/ml (b)(6).Second result (02/21/2024) : about 3000iu/ml (b)(6).Third result (02/21/2024): about 3000iu/ml (b)(6).Upon visual inspection of the sample it was hypothesized that some hemolysis sample had happened for the first result, as the sample appeared to be quite red.The customer was concerned about this slight discrepancy.There is no report of negative impact to patient management and the third result was reported out of the lab.

Manufacturer Narrative

An investigation is in process.A follow-up report will be submitted when the investigation is complete.This incident is being reported to fda because the incident occurred internationally using the alinity m ebv assay, list number 09n43-095 which received fda approval.

Manufacturer Narrative

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 ebv amp kit (list 09n43-095) lot 391395.No error codes or flags were observed for all the samples.The run passed the validity and acceptance criteria established.Customer data review: customer result log files were reviewed.The runs which involved the discrepant result were valid and met assay specification requirements.The validity of the run met assay specification requirements.A product deficiency was not identified from this analysis.Quality data review device history record / batch record review: the device history records (dhr) review for alinity m ebv amp kit (list 09n43-095) lot 391395 (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.Capa / non-conformance review: the capa review for alinity m ebv amp kit (list 09n43-095) lot 391395 (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 these lots.Complaint history review a lot specific complaint history review was performed to identify any similar complaints to the ticket being investigated, which reported a discrepant result while alinity m ebv amp kit (list 09n43-095) lot 391395.No new adverse trend was identified.A product deficiency was not identified by this evaluation.Based on the results of the investigation elements, a product deficiency alinity m ebv amp kit (list 09n43-095) lot 391395 was not identified.

• Brand Name: ALINITY M EBV AMP KIT
• Type of Device: NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF EPSTEIN-BARR VIRUS (EBV)
• 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: 18817500
• MDR Text Key: 337212340
• Report Number: 3005248192-2024-00055
• Device Sequence Number: 1
• Product Code: QLX
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K212778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2024

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 Operator: Health Professional
• Device Catalogue Number: 09N43-095
• Device Lot Number: 391395
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1