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

Catalog Number 04491785190

Device Problem Output Problem (3005)

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

Event Date 11/22/2023

Event Type  malfunction  

Event Description

There was an allegation of a questionable ferritin result from the cobas 8000 - cobas e 602 module.The initial result was 356.1 ng/ml.A new sample was measured in another laboratory using the quidelortho vitros 5600 (chemiluminescence methodology) for comparison and the result was 184.2 ng/ml.On (b)(6) 2023, the same sample was repeated on the cobas e602 and the result was 358.3 ng/ml.The same sample was sent to the other laboratory for testing using the chemiluminescence methodology and the result was 182.4 ng/ml.

Manufacturer Narrative

The cobas 8000 - cobas e 602 module serial number was (b)(6).The investigation is ongoing.

Manufacturer Narrative

Medwatch field d4 expiration date was updated.The investigation did not identify a product problem.The cause of the event could not be determined.Further investigation was not possible as the samples were not available for investigation.A general reagent issue was excluded.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18347476
• MDR Text Key: 331070060
• Report Number: 1823260-2023-04087
• Device Sequence Number: 1
• Product Code: JMG
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04491785190
• Device Lot Number: 695225
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• 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
• Patient Age: 38 YR
• Patient Sex: Female