MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FERRITIN; RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN

Catalog Number 03737551190

Device Problem Low Test Results (2458)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

The reagent kit was opened and loaded onto the instrument on (b)(6) 2023.The measuring cell was last replaced in (b)(6) 2020.The customer stated calibration and qc were acceptable.

Event Description

The initial reporter questioned the results for multiple patient samples tested for elecsys ferritin (ferritin) on a cobas e 411 immunoassay analyzer compared to a cobas e801 module.Examples of discrepant results were provided for 2 patient samples.Patient 1 initial result from the e411 analyzer was <0.5 ng/ml with a data flag.The repeat result from the e801 module was 3.2 ng/ml.Patient 2 initial result from the e411 analyzer was <0.5 ng/ml with a data flag.The repeat result from the e801 module was 8.49 ng/ml.The questionable results from the e411 analyzer were not reported outside of the laboratory.The e411 analyzer serial number was (b)(6).

Manufacturer Narrative

The field service engineer replaced the measuring cell.The investigation determined the service actions resolved the issue.

• Brand Name: ELECSYS FERRITIN
• Type of Device: RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN
• 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: 17195022
• MDR Text Key: 317924777
• Report Number: 1823260-2023-02084
• Device Sequence Number: 1
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 07/17/2023

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 03737551190
• Device Lot Number: 64725201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 07/17/2023
• 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