MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URIC ACID VER.2; URIC ACID TEST SYSTEM

Model Number	5171857190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable uric acid (ua2) results for one patient sample tested on a cobas 8000 core unit instrument.Two samples from the same patient were tested where one result was 120 umol/l and the other result was <12 umol/l.The initial result of 120 umol/l was questioned as it did not match the patient's previous results.The sample was repeated twice and the result was <12 umol/l both times.
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
B7 other relevant history was updated.General reagent issues could be ruled out as calibration and qc was inconspicuous, other patient samples were inconspicuous, and different samples from the same patient gave matching results.The investigation determined the issue was due to pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.There is no evidence to suggest a malfunction of the device.

• Brand Name: URIC ACID VER.2
• Common Device Name: URIC ACID TEST SYSTEM
• 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: 20924999
• Report Number: 1823260-2024-03662
• Device Sequence Number: 14719592
• Product Code: KNK
• UDI-Device Identifier: 04015630925124
• UDI-Public: 04015630925124
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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): 02/11/2025

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 Model Number: 5171857190
• Device Catalogue Number: 05171857190
• Device Lot Number: 802892
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/11/2025
• 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 Age: 26 YR
• Patient Sex: Male