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

Catalog Number	08057524190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with creatinine plus ver.2 assay on a cobas c 503 analytical unit, not matching the expectations.Sample 1 was drawn and tested, resulting in a creatinine value of 1496 mol/l.The high creatinine value prompted a new sample (sample 2) to be drawn and tested, resulting in a creatinine value of 29.8 mol/l.The result of 29.8 mol/l was considered normal.An emlapatch was used on the patient; likely, the skin was not cleaned after removal and before sampling.The customer suspected an interference during the sample drawing.
Additional Manufacturer Narrative
The data review of the cobas c 503 instrument showed no abnormalities or errors.The results were repeatable on the same system without alarms, and other samples processed simultaneously were unaffected.The patch contains castor oil and adhesives, which can affect sample integrity.If aspirated, these substances can cause turbidity or volume displacement, leading to questionable spectrophotometric readings.The contamination was isolated to a single tube, which was confirmed to have been drawn first.The investigation excluded hardware failure and reagent defects.The creatinine plus ver.2 reagent functioned correctly before and after the incident.The investigation did not identify a product problem.The cause of the event was consistent with a pre-analytical (external) sample contamination (exogenous substances entered the first collection tube, compromising the sample integrity).

• 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: 24701380
• Report Number: 1823260-2026-01102
• Device Sequence Number: 16068116
• 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): 04/17/2026

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: 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: 03/02/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/17/2026
• 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 Age: 4 YR
• Patient Sex: Unknown