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

Model Number PROBNP G2

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).

Event Description

The initial reporter complained of elecsys probnp ii immunoassay result from 1 patient tested on a cobas 8000 e 602 module that did not match the patient's clinical picture.The initial probnp result was "less than sensitivity." the specific result was not provided but according to package labeling, the lower limit of detection is 5.00 pg/ml.The result in question was reported to the physician.The same patient sample was retested on (b)(6) 2019.The result from the cobas e602 was again "less than sensitivity." the result from a wako system was 418 pg/ml.There was no allegation of an adverse event.The samples were aliquoted by a modular pre-analytical system.The patient sample was requested for further investigation.

Manufacturer Narrative

The customer submitted the sample for investigation.The investigation confirmed the customer¿s results and found two point mutations to the epitope of the detecting antibody.This of mutation is addressed in the product labeling.

• 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: 8683063
• MDR Text Key: 147469068
• Report Number: 1823260-2019-02126
• 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: 07/24/2019

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 Model Number: PROBNP G2
• Device Catalogue Number: 04842464190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 05/20/2019
• Supplement Dates FDA Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR