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	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient's serum/plasma sample tested with elecsys ferritin (ferr) assay on a cobas pure e402 analytical unit.Initial result: 1.69 ng/ml.No questionable result was reported outside the laboratory as the customer noticed that the result did not match the patient's previous results.The sample was then repeated.Repeat result: 49.0 ng/ml.
Additional Manufacturer Narrative
The ferr reagent expiration date was not provided.The cobas pure e402 analytical unit serial number was (b)(6).Qc was within the ranges.The investigation is ongoing.
Additional Manufacturer Narrative
A general reagent problem can be excluded because the qc prior to the event was within ranges.The alarm trace did not show any abnormality.The provided pre-analytical information did not show any abnormality.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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18538807
• Report Number: 1823260-2024-00174
• Device Sequence Number: 12651617
• Product Code: JMG
• UDI-Device Identifier: 04015630939688
• UDI-Public: 04015630939688
• Combination Product (Y/N): Y
• Initial Reporter Country: GR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 09/30/2024
• Device Catalogue Number: 07027273190
• Device Lot Number: 730731
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/15/2024
• 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