MAUDE Adverse Event Report: Roche Diagnostics Creatinine plus ver.2; Creatinine test system

Catalog Number	08057524190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable creatinine plus ver.2 results for several patient samples on a cobas c (b)(4) analytical unit.An interference with monoclonal gammopathy igm was suspected.Three patient examples were provided.Patient 1: the initial results were 337 µmol/l (serum) and 314 µmol/l (heparin plasma).The sample was tested in another laboratory on another module (cobas c 503), and the result was approximately 60 µmol/l the sample was repeated on the same module as the initial results, and the result was 300 µmol/l.Patient 2: the initial results were 338 µmol/l and 359 µmol/l (serum and heparin plasma).The results were obtained on 2 different cobas c 703 modules.A new sample was tested at a different laboratory on another module (cobas c 501), and the result was 87 µmol/l.A third sample was tested on one of the same modules as the initial sample, and the result was approximately 330 µmol/l.Patient 3: the initial result was 215 µmol/l.It was alleged that a new sample was tested at another laboratory, but the result was not provided.
Additional Manufacturer Narrative
Only one of the cobas c 703 module serial numbers was provided.The serial number was (b)(6).The investigation is ongoing.

• Brand Name: Creatinine plus ver.2
• Common Device Name: Creatinine test system
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50931151
• Report Number: 1823260-2026-03996
• Device Sequence Number: 10759200
• 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
• 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): 09/29/2026

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 Catalogue Number: 08057524190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• 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