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

Catalog Number 09315268160

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 331185045
• Report Number: 1823260-2023-04095
• Device Sequence Number: 1
• Product Code: NBC
• UDI-Device Identifier: 07613336191569
• UDI-Public: 07613336191569
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K210546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 09315268160
• Device Lot Number: 722426
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male