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

Catalog Number	07027273190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer performed a successful calibration on (b)(6) 2025.On the field service engineer's (fse) initial service visit, he inspected the module but was unable to determine what caused the event.He performed a full system decontamination, system volume check, and adjusted the sipper nozzles.He verified the module's performance by successful instrument checks.On the fse's follow-up service visit, he again verified the module's performance with successful assay recovery tests and qcs.A general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter received a questionable elecsys ferritin result from one patient sample tested on the cobas e 801 module.The initial result from the first e 801 module was 21.3 ng/ml.The first repeat result from the second e 801 module was 14 ng/ml.The second repeat result from a third module was 14.2 ng/ml.The third repeat result from a fourth module was 13.4 ng/ml.The reporter stated that the questionable result was discovered while resolving qc issues and performing lot-to-lot studies.The repeat results were deemed correct.
Additional Manufacturer Narrative
The serial number of the first e 801 module is (b)(6).The serial number of the second e 801 module (core) is (b)(6).The serial number of the third module is the serial number of the second module is (b)(6).The investigation is ongoing.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21468471
• Report Number: 1823260-2025-00553
• Device Sequence Number: 3410455
• Product Code: JMG
• UDI-Device Identifier: 04015630939688
• UDI-Public: 04015630939688
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/15/2025

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: 07027273190
• Device Lot Number: 792505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/15/2025
• 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: 23 YR
• Patient Sex: Female