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

Catalog Number	06407137190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number was (b)(6).The customer suspected that the sample (tube 1) was contaminated.The field service engineer checked and tested the system and observed no contamination and no issues.Qc was performed with successful results.The system was performing within specifications.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results from 1 patient's draw collected in 2 tubes and tested with creatinine jaffe gen.2 assay on a cobas 8000 c702 module.The patient's draw was collected in 2 different tubes: tube 1 and tube 2.Tube 1: initial result:1.98 mg/dl.The physician questioned the initial result, and the sample was then repeated.Tube 2: repeat result: 0.88 mg/dl.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
There was no indication of a performance issue with the reagent since the qc was within the ranges.No issue was observed with the calibration on the date of the event.The field service engineer verified the instrument's performance.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CREATININE JAFF¿ 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: 24038704
• Report Number: 1823260-2026-00139
• Device Sequence Number: 21085253
• Product Code: CGX
• UDI-Device Identifier: 04015630930777
• UDI-Public: 04015630930777
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: 06407137190
• Device Lot Number: 89596801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/06/2026
• 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 Age: 22 YR
• Patient Sex: Female