MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE JAFFÉ GEN. 2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number	06407137190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 701 analyzer is (b)(6).Per product labeling for the creatinine assay: "lipemia (intralipid): no significant interference up to an l index of 800." the investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with creatinine jaffé gen.2 on a cobas 8000 c 701 module.It is suspected that the high lipemia in the sample may have interfered with the assay.The affected sample had intense lipemia, with a lipemia index (l index) of 504 and a triglyceride concentration of 2736 mg/dl.Based on this, the customer centrifuged the sample, and the electrolyte tests were carried out using the supernatant.The directly processed sample initially resulted in a creatinine value of 0.24 mg/dl.The value did not agree with the patient's historical results, so the customer decided to repeat testing using the supernatant of the centrifuged sample.The repeat result was 0.86 mg/dl.
Additional Manufacturer Narrative
The investigation could not identify a product problem.Based on the available information, the issue is consistent with sample inhomogeneity due to high lipemia.

• Brand Name: CREATININE JAFFÉ GEN. 2
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21103227
• Report Number: 1823260-2025-00052
• Device Sequence Number: 8637379
• Product Code: CGX
• UDI-Device Identifier: 04015630930777
• UDI-Public: 04015630930777
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K951595
• 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): 06/27/2025

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: 06407137190
• Device Lot Number: 824093
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 06/27/2025
• 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 Sex: Unknown