MAUDE Adverse Event Report: ROCHE DIAGNOSTICS UREAL; UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN

Catalog Number	04460715190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c311 analyzer is (b)(6).A wash pipe was bent, preventing the aspiration of wash solution.This was adjusted and corrected.The photometer lamp was checked.A cell blank was performed and it was ok.The heat cut filter was changed; cell blank and photometric checks were ok.The wash settings were checked and were correctly configured.The gear pump setting was checked.The sample probe was decontaminated.Controls were run and the results were good.Precision studies were performed and were acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with ureal on a cobas 4000 c311 stand alone system.High results from the sample did not agree with the patient's historical values, so the sample was repeated.No questionable results were reported outside of the laboratory.The sample initially resulted in a urea value of 94.9 mg/dl.The sample was repeated twice, resulting in values of 76.9 mg/dl and 104.6 mg/dl.Additional urea values of 115.3 mg/dl, 88.8 mg/dl, and 105 mg/dl were also provided.It was asked, but it is not known if these values were from the same complained sample, from a different sample, or if these values were provided in error.
Additional Manufacturer Narrative
Calibration data was acceptable.Most quality control recovery was acceptable, but some results were outside of range.It was not clear if these control results were measured around the time of sample measurement.No further issues were reported by the customer.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: UREAL
• Common Device Name: UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN
• 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: 18554162
• Report Number: 1823260-2024-00193
• Device Sequence Number: 15048868
• Product Code: CDQ
• UDI-Device Identifier: 04015630920464
• UDI-Public: 04015630920464
• Combination Product (Y/N): Y
• Initial Reporter Country: CI
• 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,Followup
• Report Date (Section B): 02/02/2024

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: 06/30/2024
• Device Catalogue Number: 04460715190
• Device Lot Number: 75031401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 02/02/2024
• 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