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

Catalog Number 07027664190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys probnp ii immunoassay results for 2 patient samples on a cobas e 801 module.The serial number for the analyzer used at the customer site was requested, but not provided.(b)(6).The results were reported outside of the laboratory.

Manufacturer Narrative

The patient sample was investigated and the customer¿s nt-probnp result was confirmed.Two point mutations (r72h and e69d) in the epitope of the detection antibody were reported.Measurements with 2 elecsys probnp ii sales lot kits supplemented with additional detection antibodies for these mutations showed that the nt-probnp value of the complaint sample is not falsely lowered due to r72h or e69d mutation.This result indicates that the nt-probnp value measured with the probnp ii assay is correct and needs to be discussed from a clinical point of view.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS PROBNP II IMMUNOASSAY
• Type of Device: TEST,NATRIURETIC PEPTIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10770233
• MDR Text Key: 215320952
• Report Number: 1823260-2020-02729
• Device Sequence Number: 1
• Product Code: NBC
• Combination Product (y/n): N
• PMA/PMN Number: K072437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

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: 07027664190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1