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

Catalog Number	08057532190
Medical Device Problem Codes	Incorrect Measurement (1383); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable creatinine jaffe gen.2 results for one lipemic patient sample from the cobas c 503 analytical unit.The initial result was 0.46 mg/dl.A new sample was drawn on (b)(6) 2024 and the result was 0.639 with data flag.After high-speed centrifuge, the repeat result was 1.02 mg/dl and was reported outside of the laboratory.On (b)(6) 2024, the repeat result using the original sample was 0.98 mg/dl.
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The specific cause of the event could not be determined.The customer declined a service visit.The qc recovery was acceptable, therefore there was no indication of a performance issue with the reagent.

• 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: 19330676
• Report Number: 1823260-2024-01465
• Device Sequence Number: 3063097
• Product Code: CGX
• UDI-Device Identifier: 07613336121177
• UDI-Public: 07613336121177
• Combination Product (Y/N): Y
• Initial Reporter State: WY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: 08/31/2025
• Device Catalogue Number: 08057532190
• Device Lot Number: 75921901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/11/2024
• 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: FENOFIBRATE.; METFORMIN.
• Patient Age: 47 YR
• Patient Sex: Male