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

Catalog Number	03737551160
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2023-03161
• Device Sequence Number: 6073324
• Product Code: JMG
• UDI-Device Identifier: 04015630938940
• UDI-Public: 04015630938940
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K971833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03737551160
• Device Lot Number: 695226
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male