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

Catalog Number	04810716190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).
Event or Problem Description
We received an allegation of discrepant results for 1 patient urine sample tested for creatinine jaffe gen.2 (crej2) on a cobas 6000 c501 module.The initial result was 4 mg/dl.The repeat result was 110 mg/dl.The questionable result was not reported outside of the laboratory.The sample was repeated as the initial result was lower than the reference range.
Additional Manufacturer Narrative
No further information was provided for the investigation.Based on the information provided, the cause of the event could not be determined.

• Brand Name: CREATININE JAFFE 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23842988
• Report Number: 1823260-2025-05225
• Device Sequence Number: 13220347
• Product Code: CGX
• UDI-Device Identifier: 04015630922284
• UDI-Public: 04015630922284
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K941837
• 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): 02/13/2026

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 Catalogue Number: 04810716190
• Device Lot Number: 88689201
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/13/2026
• 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
• Patient Sex: Unknown