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

Catalog Number	05401755190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The provided qc recovery data from the date of the event was acceptable.It was found that the target draw volume was 8 milliliters (ml), while the sample collected had a draw volume of 6 ml.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable creatinine jaffé gen.2 (compensated) results for 1 patient sample on a cobas c 111 analyzer.The initial creatinine result was 1.13 mg/dl.The next day, the sample was repeated and the result was 1.15 mg/dl.The analyzer was recalibrated and an aliquot of the sample was repeated and the result was 1.58 mg/dl.A separate sample was collected on (b)(6) 2025 and tested at another laboratory and the creatinine result was 0.68 mg/dl.
Additional Manufacturer Narrative
Based on the calibration and qc data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 22770707
• Report Number: 1823260-2025-02436
• Device Sequence Number: 21228853
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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: 09/30/2026
• Device Catalogue Number: 05401755190
• Device Lot Number: 85058101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CELLCEPT; OMEGA 3; PREDNISOLON; VITAMIN D; ZESTRIL
• Patient Sex: Unknown