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

Catalog Number 09315268190

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

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

The cobas e411 disk serial number was (b)(6).The customer stated that qc was within the assigned ranges on the day of the event.The field service engineer observed that the tip of the reagent/sample pipetter was slightly dirty and 2 pinch tubes needed replacement.He cleaned the pipetter and replaced the 2 pinch tubes.He also performed measuring cell preparation maintenance.Assay performance check, calibration, and qc were performed and they were acceptable.Comparison with already processed samples was performed and the results were acceptable.The investigation is ongoing.

Event Description

We received an allegation about discrepant results for 1 patient sample tested with elecsys probnp g2 ( probnp ii) assay on a cobas e411 disk.Initial result: 36 pg/ml.This result did not match the patient's clinical status and the sample was then repeated.Repeat result: 2600 pg/ml.The repeat result was deemed to be correct.

Manufacturer Narrative

Sections d1, df2a, d2b, d4, g1 and g4 were updated.A general reagent problem can be excluded because the qc prior to the event was within ranges.The field service engineer (fse) adjusted the liquid level detection voltage, the sample/reagent pipettor, and the sipper.The fse replaced the reading cell and the pipes related to the reading circuit.He also performed a system volume check and voltage adjustment.The service actions (adjusting the liquid level detection voltage, the sample/reagent pipettor, the sipper, replacing the reading cell and the pipes related to the reading circuit, and performing a system volume check and voltage adjustment) resolved the issue.No further issues were reported afterward.The cause of the event could not be determined.

• Brand Name: ELECSYS PROBNP II
• Type of Device: TEST,NATRIURETIC PEPTIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 19046639
• MDR Text Key: 340107576
• Report Number: 1823260-2024-01044
• Device Sequence Number: 1
• Product Code: NBC
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: K961481
• 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: 05/31/2024
• 2 Devices were Involved in the Event: 1 2

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: 09315268190
• Device Lot Number: 74749801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• 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