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

Catalog Number 09315284190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 11/27/2023

Event Type  malfunction  

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 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.

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
• 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: 18337040
• MDR Text Key: 331057783
• Report Number: 1823260-2023-04050
• Device Sequence Number: 1
• Product Code: NBC
• UDI-Device Identifier: 07613336191521
• UDI-Public: 07613336191521
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K210546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 09315284190
• Device Lot Number: 73042001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/08/2024
• 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