MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FERRITIN; FERRITIN ASSAY

Catalog Number 03737551160

Device Problem Low Test Results (2458)

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number was (b)(6).The field service engineer suspected there was a bubble in the patient sample as the customer could not reproduce the issue.Calibration and qc were performed and were acceptable.The investigation is ongoing.

Event Description

There was an allegation of a questionable ferritin elecsys v2 result from the cobas e411 rack analyzer.The initial result was 1.42 ng/ml and was reported outside of the laboratory as <2 ng/ml.The doctor questioned the result and the repeat result was 74.18 ng/ml.The repeat result was believed correct.

Manufacturer Narrative

The investigation determined the event was due to customer handling as they were not using the required rack adapters when processing 13mm tubes.The calibration and qc data were acceptable.The analyzer alarm trace contained errors that are indicators of possible poor sample quality.No product issue was found.

• Brand Name: ELECSYS FERRITIN
• Type of Device: FERRITIN ASSAY
• 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: 17860670
• MDR Text Key: 324797026
• Report Number: 1823260-2023-03161
• Device Sequence Number: 1
• Product Code: JMG
• UDI-Device Identifier: 04015630938940
• UDI-Public: 04015630938940
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K971833
• 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: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03737551160
• Device Lot Number: 695226
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• 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: 71 YR
• Patient Sex: Male