MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE JAFFE GEN.2 (COMPENSATED); CREATININE TEST

Catalog Number	05401755190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable creatinine jaffe gen.2 (compensated) result from one patient sample tested on the cobas c 111 analyzer.The initial result was 3.2 umol/l.The first repeat result was 128.2 umol/l.The second repeat result was 123.5 umol/l.No questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
The cobas c 111 serial number is (b)(6).The customer stated that the patient's sample was highly lipemic.The investigation is ongoing.

• Brand Name: CREATININE JAFFE GEN.2 (COMPENSATED)
• Common Device Name: CREATININE TEST
• 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: 22873010
• Report Number: 1823260-2025-02588
• Device Sequence Number: 16045134
• Product Code: CGX
• UDI-Device Identifier: 04015630926824
• UDI-Public: 04015630926824
• Combination Product (Y/N): N
• Initial Reporter Country: BK
• 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
• Report Date (Section B): 08/22/2025

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: 05401755190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/22/2025
• 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