MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE JAFFE GEN.2; CREATININE, ALKALINE PICRATE COLORIMETRY

Catalog Number	08057532190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 2 patient samples tested for creatinine jaffe gen.2 (creaj2) on a cobas c 503 analytical unit.For both patients, the initial results were reported outside of the laboratory and a 2nd sample was requested.The results for the 2nd sample were not provided.The original tube was then repeated.Patient 1 initial result was 0.17 mg/dl with a data flag.The repeat result was "comparable to the previous history" (3 mg/dl); the specific result was not provided.Patient 2 initial result was 0.14 mg/dl with a data flag.The repeat result was "comparable to the previous history" (8 mg/dl); the specific result was not provided.
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).
Additional Manufacturer Narrative
Based on the limited information, the investigation did not identify a specific product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
An additional investigation conclusion code was added.

• Brand Name: CREATININE JAFFE GEN.2
• Common Device Name: CREATININE, ALKALINE PICRATE COLORIMETRY
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21114937
• Report Number: 1823260-2025-00075
• Device Sequence Number: 18010928
• Product Code: CGX
• UDI-Device Identifier: 07613336121177
• UDI-Public: 07613336121177
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K951595
• 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,Followup
• Report Date (Section B): 02/11/2025

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 Catalogue Number: 08057532190
• Device Lot Number: ASKU
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 01/27/2025; 02/07/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/28/2025; 02/11/2025
• 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
• Patient Sex: Unknown