MAUDE Adverse Event Report: Abbott Molecular, Inc. Alinity m BKV AMP Kit; NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF BK VIRUS (BK) DNA

Catalog Number	09N85-095
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a misquantitation low result while using the alinity m bkv assay.The customer stated that their bkv results appear lower when compared to results obtained on another platform; however, they were unable to specify which platform was used for comparison.The customer also indicated that this situation is not considered a discrepancy at this time.The customer stated that the issue was not so much about any one questionable result, but rather an inquiry to demonstrate that the instrument and the assay are performing within expectations.The laboratory manager forwarded an email from the medical director of the kidney transplantation from (b)(6) 2026, in which it was stated they were "seeing a worrying trend with biopsy proven polyoma nephropathy with pretty low titers bk pcr performed at dlo/quest labs (this site).There is a concern that the dlo/quest pcr is not correlating well with other standard labs.A patient had biopsy proven polyoma nephropathy despite low titers bk pcr.Jc pcr is negative.The patient was recently admitted to the hospital and had a bk pcr sent by mistake to viracor (another diagnostic company) and the titers were almost 7 times more than the dlo lab." the customer does not have information regarding the sample mentioned in the physician's email (cited above).There were no allegations of discrepant results from any other provider.There was no report of impact to patient management.No additional information was available.
Additional Manufacturer Narrative
An investigation is in process.A follow-up report will be submitted when the investigation is complete.

• Brand Name: Alinity m BKV AMP Kit
• Common Device Name: NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF BK VIRUS (BK) DNA
• Manufacturer (Section D): Abbott Molecular, Inc.; 1300 e. touhy ave.; des plaines IL 60018 -331
• Manufacturer (Section G): Abbott Molecular, Inc.; 1300 e. touhy ave.; des plaines IL 60018 -331
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018--331 ; +1(224)206-4064
• MDR Report Key: 50872763
• Report Number: 3005248192-2026-00089
• Device Sequence Number: 18447441
• Product Code: QMI
• UDI-Device Identifier: 00884999050709
• UDI-Public: (01)00884999050709(10)443253(17)270206(240)09N85-095
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K241921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 09N85-095
• Device Lot Number: 443253
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male