MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE JAFFÉ GEN.2; 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	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A general reagent issue was excluded.The sample clotting time was 25 minutes.For most tube manufacturers, the recommended clotting time is a minimum of 30 minutes.It was noted that there was no evidence of the photometer being replaced.It is recommended the photometer lamp be replaced every 6 months.The investigation found the issue was due to pre-analytical handling issues.The investigation did not identify a product problem.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The calibration was acceptable.Qc with lot 598376 was mostly in range with some outliers.Qc with lot 595441 was within specification.The last preventative maintenance was performed on 29-nov-2023.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable creatinine jaffé gen.2 results for 1 patient sample on a cobas c 111 analyzer.The initial result was 3.90 mg/dl.The repeated result was 0.8 mg/dl.The repeated result was believed to be correct.

• Brand Name: CREATININE JAFFÉ GEN.2
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20602179
• Report Number: 1823260-2024-03182
• Device Sequence Number: 8144394
• Product Code: CGX
• UDI-Device Identifier: 04015630926824
• UDI-Public: 04015630926824
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 12/11/2024

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 Catalogue Number: 05401755190
• Device Lot Number: 595270
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/11/2024
• 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
• Patient Sex: Unknown