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 patient sample was not available for further investigation.The investigation did not identify a product problem.The cause of the event could not be determined.The event occurred in: (b)(6).

Event Description

The initial reporter complained of questionable elecsys probnp ii immunoassay results for 1 patient tested on a cobas e 411 immunoassay analyzer.The customer did not believe that the probnp results were matching the patient's clinical picture.The probnp results from both run 1 and run 2 were considered "less than sensitivity." no numerical results were provided.The "less than sensitivity" results were reported to the physician who questioned the results as the patient had been diagnosed with heart failure and atrial fibrillation.There was no allegation of an adverse event.The cobas e411 serial number was either (b)(4).

• Brand Name: ELECSYS PROBNP II IMMUNOASSAY
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8663771
• MDR Text Key: 146930122
• Report Number: 1823260-2019-02056
• 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,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/03/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/03/2019
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1