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

Catalog Number 09315268190

Device Problem Non Reproducible Results (4029)

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

Event Date 09/07/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of questionable probnp g2 elecsys results from cobas 8000 - cobas e 602 module serial number (b)(4).The initial result was 35000 ng/l or more.The repeat result with a 1:5 dilution was 26491 ng/l.The repeat result with a 1:10 dilution was 27258 ng/l.The repeat result undiluted was 35000 ng/l or more.The repeat result with a 1:2 dilution was 30167 ng/l.This result was reported outside of the laboratory.It was found the sample diluent had passed the onboard stability.It was replaced and the sample was repeated with similar results.No specific data was provided.

Manufacturer Narrative

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: TEST,NATRIURETIC PEPTIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15512177
• MDR Text Key: 306340110
• Report Number: 1823260-2022-03000
• Device Sequence Number: 1
• Product Code: NBC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072437
• 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: 11/09/2022

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: 09315268190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 11/04/2022
• Supplement Dates FDA Received: 11/09/2022
• 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