MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FERR4; FERRITIN

Catalog Number	08057648190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c303 analyzer serial number was (b)(6).Competitor method 1 was mini vidas.Competitor method 2 was not provided.
Event or Problem Description
The initial reporter complained of discrepant high results for 1 patient sample tested for ferr4 on a cobas c 303 analytical unit compared to two competitor methods.On 14-feb-2024 the initial result from the c303 analyzer was 46.7 ng/ml.On 15-feb-2024 the repeat result from competitor method 1 was 2.95 ng/ml.The repeat result from competitor method 2 was < 3 ng/ml.A new sample was obtained and the result from the c 303 analyzer was 49 ng/ml.
Additional Manufacturer Narrative
Calibration and qc were acceptable.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: FERR4
• Common Device Name: FERRITIN
• 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: 18866633
• Report Number: 1823260-2024-00708
• Device Sequence Number: 3338460
• Product Code: DBF
• UDI-Device Identifier: 07613336121238
• UDI-Public: 07613336121238
• Combination Product (Y/N): Y
• Initial Reporter Country: MO
• PMA/510(K) Number: K100538
• 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): 03/25/2024

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: 04/30/2025
• Device Catalogue Number: 08057648190
• Device Lot Number: 726862
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 03/25/2024
• 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 Age: 42 YR
• Patient Sex: Female