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

Model Number	09N43-095
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Elevated complaint investigation will be initiated.
Event or Problem Description
The customer reported discrepant (false detected) alinity ebv results with lower limit of quantification (lloq).Sample id, alinity result, date, mayo result : (b)(6).Mayo results were generated using an alternative platform (roche molecular).There was no impact to patient management for the sample ids listed above.Mayo results were released to provider.The reported event was considered false detected.
Additional Manufacturer Narrative
The ticket was reported for discrepant results (false positive) below lower limit of quantification (

• Brand Name: ALINITY M EBV AMPLIFICATION REAGENT KIT
• Common Device Name: NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF EPSTEIN-BARR VIRUS (EBV)
• 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: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2242064064
• MDR Report Key: 16450192
• Report Number: 3005248192-2023-00118
• Device Sequence Number: 5530869
• Product Code: QLX
• UDI-Device Identifier: 00884999049505
• UDI-Public: 00884999049505
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K212778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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 Expiration Date: 04/06/2023
• Device Model Number: 09N43-095
• Device Catalogue Number: 09N43-95
• Device Lot Number: 381017
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown