MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE JAFFE GEN.2 (COMPENSATED); CREATININE TEST

Catalog Number	05401755190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a discrepant low result for 1 patient sample tested for creatinine jaffe gen.2 (compensated) (creaj2) on a cobas c 111 analyzer.The initial result was 0.67 mg/dl.The repeat result from a different laboratory was 1.03 mg/dl.The repeat result after recalibration was 1.02 mg/dl.
Additional Manufacturer Narrative
The c111 analyzer serial number was (b)(6).
Additional Manufacturer Narrative
The customer's calibration signals and qc results were unstable.The lamp was replaced less than 6 months ago.The reagent is used within 2-3 days.Unopened reagent packs are stored at room temperature.The sample/reagent syringe was cleaned; the water inlet filter and water tank were cleaned.No other assays were affected.A special wash is programmed on the instrument.Based on the calibration and qc data provided, the investigation determined the event was consistent with an environmental issue.Creaj2 has a high ph of >13.5.High concentrations of ambient co2 can cause a reduction in the ph, which can lead to lower creaj2 qc and patient results.The drift in recovery can be improved by calibration.The investigation did not identify a product problem.

• Brand Name: CREATININE JAFFE GEN.2 (COMPENSATED)
• Common Device Name: CREATININE TEST
• 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: 24500355
• Report Number: 1823260-2026-00759
• Device Sequence Number: 10510086
• Product Code: CGX
• UDI-Device Identifier: 04015630926824
• UDI-Public: 04015630926824
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K941837
• 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): 04/02/2026

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: 05401755190
• Device Lot Number: 91928201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/02/2026
• 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