MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PROBNP II; NATRIURETIC PEPTIDE TEST

Catalog Number	09315284190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The probnp ii reagent expiration date was not provided.The cobas e801 analytical unit serial number was (b)(6).The sample was requested for investigation on 14-feb-2025.The investigation is ongoing.
Event or Problem Description
We received an allegation about questionable results for 1 patient sample not matching the patient's clinical diagnosis when tested with elecsys probnp g2 (probnp ii) assay on a cobas e801 analytical unit.The customer initially tested the sample on a vitros system and the result was below detectability.The customer tested the sample on an e801 and the result was also below detectability.The customer then diluted the sample and tested it again and the result was the same as the previous one.The customer sent the sample to another laboratory for re-testing and the bnp result was about 300 pg/ml.On 05-mar-2025, the sample was provided for investigation where it was tested on a 2nd e801 analyzer resulting in a probnp ii value of 5.00 pg/ml and accompanied by a data flag.The customer suspected a genetic mutation.
Additional Manufacturer Narrative
The sample was received for investigation on 27-mar-2025.The sample was tested with 2 elecsys probnp ii lot kits with additional detection antibodies for the mutations on a cobas e801 immunoassay analyzer.The investigation results detected the mutation in the sample, leading to false-negative test results for elecsys probnp ii.The customer¿s result was confirmed.This type of point mutation is extremely rare.The investigation did not identify a product problem.The cause of the event was due to the sample containing an interfering factor.

• Brand Name: ELECSYS PROBNP II
• Common Device Name: NATRIURETIC PEPTIDE TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21559941
• Report Number: 1823260-2025-00681
• Device Sequence Number: 17237050
• Product Code: NBC
• UDI-Device Identifier: 07613336191521
• UDI-Public: 07613336191521
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 09315284190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown