MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PCT BRAHMS ELECSYS COBAS; PCT BRAHMS ASSAY

Catalog Number 09318747190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 02/15/2023

Event Type  malfunction  

Event Description

The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys brahms pct (pct) on a cobas e 801 analytical unit.The initial result was 86 ng/ml.The repeat result was 0.142 ng/ml.It is not known if the questionable result was reported outside of the laboratory.The repeat result was believed to be correct.The e801 module serial number was (b)(4).

Manufacturer Narrative

The customer did not provide any additional information for investigation.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: PCT BRAHMS ELECSYS COBAS
• Type of Device: PCT BRAHMS ASSAY
• 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: 16506736
• MDR Text Key: 311243349
• Report Number: 1823260-2023-00736
• Device Sequence Number: 1
• Product Code: NTM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173927
• 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: 05/09/2023

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: 09318747190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 05/09/2023
• 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