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 09N43-091

Device Problem High Test Results (2457)

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

Event Date 02/23/2024

Event Type  malfunction  

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 09n43-091, which is the same/similar to the alinity m ebv assay, list number 09n43-095 , which received fda approval.As the event occurred with multiple lots, mdr 3005248192-2024-00073 has been submitted for lot 385725.

Event Description

The customer reported high results for the ebv assay when using the alinity m compared to the m2000 system.In (b)(6) 2024, the customer transitioned from utilizing the m2000 ebv testing platform to the alinity m ebv platform.However, upon report generation, laboratory personnel noted that the average ebv values obtained on the alinity m platform were consistently higher than those obtained on the m2000 platform.The most significant differences were observed in two cases (sid (sample id): (b)(6)).Consequently, the customer aliquoted the latest patient samples (from the same plasma tube) into 2-4 tubes and conducted repeated testing on both the alinity m and m2000 platforms.Despite satisfactory within-platform repeatability, ebv values were consistently higher on the alinity m platform compared to the m2000 platform.Sid (b)(6) was tested on alinity m on (b)(6) 2024 (5.45 log iu/ml) and m2000 on (b)(6) 2024 (3.12 log iu/ml).Upon reviewing the ebv viral load history for these two patients, it was observed that ebv values surged following the transition to the alinity m platform.The customer also tested ebv reserve specimens from three other patients in the past month and found that ebv values on the alinity m platform consistently exceeded those on the m2000 platform, with the highest discrepancy observed at 1.24 log iu/ml.The results were reported outside of the laboratory.There was no impact to patient management as described by the attending physicians to the laboratory team.

• 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: 19045506
• MDR Text Key: 339560211
• Report Number: 3005248192-2024-00079
• Device Sequence Number: 1
• Product Code: QLX
• UDI-Device Identifier: 00884999050440
• UDI-Public: (01)00884999050440(10)394246(17)240918(240)09N43-091
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 04/04/2024

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: 09N43-091
• Device Lot Number: 394246
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/03/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1