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

Catalog Number	09315268160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient's serum sample that was auto-diluted onboard while tested with elecsys probnp g2 (probnp ii) assay on a cobas e411 immunoassay analyzer when compared to an e601 immunoassay analyzer.Initial result: 3600 pg/ml accompanied by a data flag and diluted as a 100x auto-dilution.The result was questioned by the provider as it did not match the patient's clinical history.The sample was then repeated on e601 and the repeat result was 970 pg/ml.The repeat result was deemed to be correct.Reportedly, an amended report with the correct results was issued.
Additional Manufacturer Narrative
The probnp ii reagent expiration date was not provided.The cobas e411 disk serial number was (b)(6).Qc was in range before and after the sample was tested.The field service engineer did a performance check and the instrument was performing within specifications.Precision studies were performed and they were within specifications.The customer performed qc and was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The investigation determined the event was consistent with a product handling issue at the customer site (re-using barcodes, re-using disk positions, programming the test for dilution manually, or altering the instrument manager rules).

• 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: 18354461
• Report Number: 1823260-2023-04095
• Device Sequence Number: 6594693
• Product Code: NBC
• UDI-Device Identifier: 07613336191569
• UDI-Public: 07613336191569
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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: 09315268160
• Device Lot Number: 722426
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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