MAUDE Adverse Event Report: ROCHE DIAGNOSTICS UREAL; UREA NITROGEN TEST SYSTEM

Catalog Number	05171873190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient's sample tested with urea (ureal) assay on a cobas 8000 c702 module serial number 22g7-01.On (b)(6) 2023: initial result: 42.4 mmol/l > test (with a data flag).1st rerun result: 1.0 mmol/l (the sample was automatically rerun by the system).2nd rerun result: 41.5 mmol/l (with no data flag and was tested with dilution).This result was believed to be correct.No questionable results were reported outside the laboratory.
Additional Manufacturer Narrative
Calibration and qc were acceptable.Precision testing was completed with passing results.Two "abnormal aspiration" errors were observed on the alarm trace data.Based on the information provided, a general instrument issue was excluded.A general reagent issue was excluded as qc was acceptable.The investigation did not identify a product problem.The cause of the event could not be determined.H3 other text : na.

• Brand Name: UREAL
• Common Device Name: UREA NITROGEN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16808264
• Report Number: 1823260-2023-01389
• Device Sequence Number: 14950338
• Product Code: CDQ
• UDI-Device Identifier: 04015630925131
• UDI-Public: 04015630925131
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• PMA/510(K) Number: K972250
• 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
• Report Date (Section B): 04/25/2023

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: 06/30/2023
• Device Catalogue Number: 05171873190
• Device Lot Number: 66366901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/25/2023
• 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