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

Catalog Number	09315284190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter establishment name: (b)(6) the analyzer's serial number is (b)(6).The field service representative found abnormalities with qc on the measuring cell.He replaced the pinch valves and pinch tube for the syringe and performed liquid flow path cleaning.He performed checks and tests with acceptable results.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys probnp ii results for 1 patient sample on a cobas e 801 analytical unit.The initial result was 385 pg/ml.The clinician questioned the result and requested that the sample be repeated because the patient's result is typically around 10,000 pg/ml.The repeated result was 19265 pg/ml.
Additional Manufacturer Narrative
The calibration and qc were acceptable.A general reagent issue was excluded.The investigation could not determine if the service actions were related to the issue.The investigation could not determine a clear root cause.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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21700473
• Report Number: 1823260-2025-00894
• Device Sequence Number: 8593376
• Product Code: NBC
• UDI-Device Identifier: 07613336191521
• UDI-Public: 07613336191521
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/30/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 09315284190
• Device Lot Number: 834627
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/30/2025
• 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