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

Catalog Number	07027273190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The qcs were in range.The level 1 calibration and level 2 calibration results were slightly below the approximate expected range.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable elecsys ferritin (ferritin) result from one patient sample tested on the cobas e 801 analytical unit with serial number 20x6-04.The initial result was reported to the medical personnel and was rejected as it did not fit the medical state and the previous results of the patient.The initial result of the undiluted sample was 64.5 ng/ml.The first repeat result of the undiluted sample was 2000 ng/ml with a data flag.The second repeat result using a diluted sample was 4370 ng/ml.This repeat result was deemed correct as it is in line with the previous results and the clinical picture.
Additional Manufacturer Narrative
The most observed alarm in the alarm trace was "reagent probe liquid-level detection (lld)".This suggests a pre-analytic reagent handling issue.A general reagent issue was not identified.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FERRITIN
• Common Device Name: 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: 16522830
• Report Number: 1823260-2023-00761
• Device Sequence Number: 12376598
• Product Code: JMG
• UDI-Device Identifier: 04015630939688
• UDI-Public: 04015630939688
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K971833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 07027273190
• Device Lot Number: 65213901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown