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

Catalog Number 09315268160

Device Problems Low Test Results (2458); Insufficient Information (3190); Non Reproducible Results (4029)

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

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

The lot number and expiration date of the probnp reagent were requested, but not provided.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys probnp ii on two cobas e 601 module analyzers.It was asked, but it is not known which of the two analyzers was used for each measurement.The sample initially resulted in a probnp value of < 36 pg/ml when tested on the first e601 analyzer.The physician questioned the result.The sample was repeated on the second e601 analyzer, resulting in a probnp value of 8000 pg/ml.The repeat value was deemed correct.

Manufacturer Narrative

The customer stated they had no issues with calibrations and controls passed.The field service engineer could not determine any issues with the instruments.The instruments were inspected, the sample probe voltage was checked, and precision studies were performed.The investigation could not identify a product problem.The cause of the event could not be determined.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• Brand Name: ELECSYS PROBNP II
• Type of Device: NATRIURETIC PEPTIDE TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18445077
• MDR Text Key: 331933858
• Report Number: 1823260-2024-00033
• Device Sequence Number: 1
• Product Code: NBC
• UDI-Device Identifier: 07613336191569
• UDI-Public: 07613336191569
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K210546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024
• 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: 09315268160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1