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

Catalog Number	03263991190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with creatinine plus ver.2 (crep2) assay on a cobas 6000 c501 module.Initial result: 425.4 ¿mol/l.The customer questioned the initial result and repeated the sample.Repeat result: 74.3 ¿mol/l.The repeat result of 74.3 ¿mol/l was deemed to be correct.Reportedly, an amended report with the correct result was issued.
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).The qc was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
Following the installation of the special wash, the customer conducted carry-over experiments as outlined in the troubleshooting guide.The results showed no visible carry-over, indicating successful resolution.The instrument was performing within specifications.The investigation did not identify a product problem.The cause of the event was consistent with a user error where the customer did not follow the instructions for special wash installation as recommended in the product labeling (integrated special wash requirement).

• 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: 22131213
• Report Number: 1823260-2025-01702
• Device Sequence Number: 8371516
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 06/24/2025

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 03263991190
• Device Lot Number: 85802001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/24/2025
• 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