MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FERRITIN; FERRITIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number 04491785190

Device Problem High Test Results (2457)

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

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

The calibration data provided showed recovery below the target range.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys ferritin results for 2 patient samples on a cobas e 411 immunoassay analyzer compared to a siemens centaur analyzer.For sample 1, the e411 ferritin result was 373.6 ng/ml.The repeat result on the centaur analyzer was 226 ng/ml.For sample 2, the e411 ferritin result was 760 ng/ml.The repeat result on the centaur analyzer was 506 ng/ml.No questionable results were reported outside of the laboratory.The e411 analyzer serial number was requested but not provided.

Manufacturer Narrative

The e411 serial number was (b)(6).The qc recovery data provided was acceptable.Based on the available data, a reagent issue could be excluded.The investigation determined that the result differences generated between the different methods are consistent with methodological differences.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and the standardized methodology used.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ELECSYS FERRITIN
• Type of Device: FERRITIN IMMUNOLOGICAL TEST SYSTEM
• 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: 16456308
• MDR Text Key: 310423465
• Report Number: 1823260-2023-00609
• Device Sequence Number: 1
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K971833
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 04491785190
• Device Lot Number: 64725602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• 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