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

Catalog Number	03263991190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable creatinine plus ver.2 result from the cobas integra 400 plus for two patients.Patient 1's initial result was 2.02 mg/dl, and the repeat result was 1.0 mg/dl.Patient 2's initial result on (b)(6) 2025 was 1.21 mg/dl, accompanied by a data flag.The repeat result was 0.59 mgdl.The customer also provided questionable uric acid ver.2 results for one patient and calcium gen.2 results for one patient.This medwatch will cover the creatinine plus ver.2 assay.See medwatch with a1 patient identifier (b)(6) for the uric acid ver.2 assay.See medwatch with a1 patient identifier (b)(6) for the calcium gen.2 assay.
Additional Manufacturer Narrative
The cobas integra 400 plus serial number is (b)(6).The qc and calibration were passing at the time of the event.The investigation is ongoing.
Additional Manufacturer Narrative
The water quality is 3 s/cm; based on the technical specifications, the limits for water conductivity are < 1.5 s/cm.The customer changed the water source, which had high conductivity, and they are reviewing their preanalytical steps.The photometer lamp was last replaced on 23-sep-2025 and is to be exchanged after 800 hours in operating or standby mode.The investigation determined that a general reagent or analyzer problem was not present because the qc prior to the event was within ranges.The investigation was unable to determine a direct root cause as there was limited information available.The most likely root cause is a combination of different customer handling issues (pre-analytics, maintenance actions, water quality).

• 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: 23876623
• Report Number: 1823260-2025-05312
• Device Sequence Number: 18554262
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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): 02/06/2026

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: 03263991190
• Device Lot Number: 88922601
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/06/2026
• 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