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

Catalog Number	05168589190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The crep2 reagent lot number was 87513901 with an expiration date of 31-jan-2026.
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for creatinine plus ver.2 (crep2) on a cobas 8000 cobas c 701 module.The initial result was 9.94 mg/dl.The physician questioned this result.The sample was repeated on a different c module with a result of 1.34 mg/dl.The repeat result was believed to be correct.
Additional Manufacturer Narrative
Section d, device identification, was updated.Relevant fields of sections d and g were updated.The c701 module serial number was (b)(6).
Additional Manufacturer Narrative
Calibration and qc were acceptable.Abnormal aspiration and sample short errors were observed on the alarm trace data.The field service engineer (fse) did not identify any issues.The instrument was checked, and multiple precision checks were acceptable.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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 46250-0457
• MDR Report Key: 23860439
• Report Number: 1823260-2025-05262
• Device Sequence Number: 13174276
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2026

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 05168589190
• Device Lot Number: 87513901
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 01/30/2026
• Initial Report FDA Received Date: 12/21/2025
• Supplement Report FDA Received Date: 01/27/2026; 02/17/2026
• 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