MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE JAFFÉ GEN.2; CREATININE TEST

Catalog Number	05401755190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The crej2 reagent expiration date was not provided.The cobas c111 system serial number was (b)(6).Qc was within the assigned ranges on the day of the event.The maintenance was last performed on (b)(6) 2024.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's plasma sample tested with creatinine jaffé gen.2 (crej2) assay on a cobas c111 system.Initial result: 394.8 mol/l.The customer doubted the result.The sample was repeated 3 times and the repeat results were 90.3 mol/l, 90.5 mol/l, and 89.3 mol/l.No questionable result was reported outside the laboratory.
Additional Manufacturer Narrative
The sample centrifugation time and force were not performed as recommended.The investigation did not identify a product problem.The cause was consistent with a preanalytic issue at the customer's site.Preanalytics are within the customer's responsibility.

• 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: 18896332
• Report Number: 1823260-2024-00748
• Device Sequence Number: 7589034
• Product Code: CGX
• UDI-Device Identifier: 04015630926824
• UDI-Public: 04015630926824
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 04/04/2024

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: 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: 02/19/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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