MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE PLUS VER.2; ENZYMATIC METHOD, CREATININE

Catalog Number	03263991190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The sample is not available to be returned for investigation as it has been discarded.The field service representative inspected the instrument and found no abnormalities.He proactively replaced and adjusted the gear pump head, proactively replaced and adjusted needles, checked fill levels, and performed tests with acceptable results.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable creatinine plus ver.2 results for 1 patient sample on a cobas 8000 cobas c 502 module.A serum sample was collected from a patient undergoing eltrombopag therapy.The sample was coffee-brown in color.The initial result was approximately 120 umol/l.The customer alleged that the c 502 analyzer failed to detect the sample discoloration, and the clinic was advised to request creatinine results using a blood gas analyzer.The sample was repeated on an unknown blood gas analyzer, resulting in a creatinine value of approximately 160 umol/l.
Additional Manufacturer Narrative
The investigation excluded eltrombopag as a direct chemical interferent for enzymatic creatinine at concentrations up to 500 mol/l.The drug itself does not react with the assay reagents.No significant interference was found for creatinine.The investigation determined the discrepancy was consistent with the physical/spectral properties of the discolored sample, which interfered with the photometer's light absorbance at the specific wavelengths used for the enzymatic creatinine reaction.The investigation also found the issue consistent with intermittent hardware performance issues, which could have affected the consistency of the sample aspiration or the efficiency of the cuvette rinsing for this specific, highly pigmented specimen.Further investigation and root cause analysis were not possible because the sample was not available for testing/investigation.The investigation did not identify a product problem.

• Brand Name: CREATININE PLUS VER.2
• Common Device Name: ENZYMATIC METHOD, CREATININE
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23801192
• Report Number: 1823260-2025-05097
• Device Sequence Number: 7686037
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K024098
• 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): 03/23/2026

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: 12/31/2025
• Device Catalogue Number: 03263991190
• Device Lot Number: 86413201
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 03/23/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ELTROMBOPAG THERAPY
• Patient Sex: Unknown