MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE PLUS VER.2; CREATININE TEST SYSTEM

Catalog Number	08057524190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The alarm trace showed abnormal aspiration" alarms.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable creatinine plus ver.2 results for 1 patient on a cobas c 503 analytical unit.The initial result was 555 mol/l, and the repeated result was 525 mol/l.The physician questioned the results, and the sample was repeated.The repeated results were 641 mol/l, 65.3 mol/l, 366 mol/l, 368 mol/l, 367 mol/l, 367 mol/l, and 368 mol/l.A second sample (collected at the same time as the first sample) from the same patient was tested, and the results were 65.0 mol/l, 65.3 mol/l, 65.3 mol/l, 66.5 mol/l, 66.2 mol/l.
Additional Manufacturer Narrative
The calibration and qc were acceptable.A general product problem was excluded.Pre-analytical issues could not be excluded.The investigation did not identify a product problem.

• Brand Name: CREATININE PLUS VER.2
• Common Device Name: CREATININE TEST SYSTEM
• 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: 24627982
• Report Number: 1823260-2026-00976
• Device Sequence Number: 18317400
• Product Code: JFY
• UDI-Device Identifier: 07613336121160
• UDI-Public: 07613336121160
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/22/2026

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: 07/31/2026
• Device Catalogue Number: 08057524190
• Device Lot Number: 91675101
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/22/2026
• 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