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

Catalog Number	09744959190
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure e 402 analytical unit serial number is (b)(6).The patient's samples were received for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys probnp ii results from four samples from the same patient tested on the cobas e 402 analytical unit.On (b)(6) 2025, the result from the analyzer was <5.00 pg/ml with a data flag.The reporter stated that the results were discrepant with the patient's clinical findings.On (b)(6) 2025, the investigation laboratory reran the patient's samples.The result of the patient's sample collected on (b)(6) 2025 was <5.00 pg/ml with a data flag.The result of the patient's sample collected on (b)(6) 2025 was <5.00 pg/ml with a data flag.The result of the patient's sample collected on (b)(6) 2025 was <5.00 pg/ml with a data flag.
Additional Manufacturer Narrative
The investigation tested the patient sample for elecsys probnp ii, which confirmed the customer's results.The investigation also tested the patient sample for interferents.The investigation confirmed the presence of an extremely rare point mutation in the patient sample not detected by the elecsys probnp ii assay, product labeling states, "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.In extremely rare cases (global incidence: < 1 in 10 million; reported from japan), patients may show false low results when tested with the assay kit (values undetectable) due to a nt-probnp variant.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation determined that the mutation in the patient's sample was the cause of the event.The investigation did not identify a product problem.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22714435
• Report Number: 1823260-2025-02391
• Device Sequence Number: 9393855
• Product Code: NBC
• UDI-Device Identifier: 07613336217689
• UDI-Public: 07613336217689
• 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): 10/29/2025

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: 09744959190
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 10/29/2025
• 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