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

Catalog Number	05401470190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 111 analyzer serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable creatinine plus ver.2 results for one sample from the cobas c 111 analyzer.The initial result was 434.8 umol/l, and the repeat result was 62.3 umol/l.The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
Due to the limited information provided, the investigation was unable to determine a specific root cause.A reagent issue was not likely since qc and calibration data were inconspicuous.There was no product problem identified.

• 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: 22802464
• Report Number: 1823260-2025-02480
• Device Sequence Number: 12676788
• Product Code: JFY
• UDI-Device Identifier: 04015630926862
• UDI-Public: 04015630926862
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/18/2025

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: 10/31/2025
• Device Catalogue Number: 05401470190
• Device Lot Number: 85802801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/18/2025
• 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