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	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e801 analytical unit serial number was (b)(6).Calibration was acceptable.The alarm trace showed no abnormalities.A general reagent problem can be excluded because the qc prior to the event was within ranges.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 3 patients' samples tested with elecsys probnp g2 (probnp ii) stat assay on a cobas e801 immunoassay analyzer when compared to a cobas pro analyzer.Sample 1: initial result: 1266 pg/ml.Repeat result: 34930 pg/ml (tested on cobas pro).Sample 2: initial result: <50 pg/ml.Repeat result: 751 pg/ml (tested on cobas pro).Sample 3: initial result: <50 pg/ml.Repeat result: 528 pg/ml (tested on cobas pro).No questionable results were reported outside the laboratory as they did not match the patients' previous results.
Additional Manufacturer Narrative
Only one image was provided for investigation of probnp ii stat.The image showed a slightly dirty active gripper.A vibration of the tube was observed which might have been caused by a loose grip of the active gripper.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 18337040
• Report Number: 1823260-2023-04050
• Device Sequence Number: 15129169
• Product Code: NBC
• UDI-Device Identifier: 07613336191521
• UDI-Public: 07613336191521
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 01/08/2024

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 Expiration Date: 10/31/2024
• Device Catalogue Number: 09315284190
• Device Lot Number: 73042001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/08/2024
• 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: Unknown