MAUDE Adverse Event Report: ROCHE DIAGNOSTICS UA2; URIC ACID TEST SYSTEM

Model Number	UA G2
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for nine patient samples tested with ua2 uric acid ver.2 on cobas pro c 503 analytical unit serial number (b)(4).The initial values were reported outside of the laboratory to the doctor.The first sample initially resulted in a uric acid value of 0.5 mg/dl and it repeated as 3.12 mg/dl.The second sample initially resulted in a uric acid value of 0.7 mg/dl and it repeated as 5.89 mg/dl.The third sample initially resulted in a uric acid value of 1.6 mg/dl and it repeated as 5.06 mg/dl.The fourth sample initially resulted in a uric acid value of 0.4 mg/dl and it repeated as 4.13 mg/dl.The fifth sample initially resulted in a uric acid value of 0.4 mg/dl and it repeated as 3.63 mg/dl.The sixth sample initially resulted in a uric acid value of 0.7 mg/dl and it repeated as 4.81 mg/dl.The seventh sample initially resulted in a uric acid value of 1.1 mg/dl and it repeated as 5.48 mg/dl.The eighth sample initially resulted in a uric acid value of 2.4 mg/dl and it repeated as 4.2 mg/dl.The ninth sample initially resulted in a uric acid value of 0.8 mg/dl and it repeated as 4.2 mg/dl.
Additional Manufacturer Narrative
Calibration and controls recovered within specifications.A general product issue can be excluded.Upon review of the alarm trace, abnormal aspiration alarms took place on (b)(6)2023 and (b)(6)2023.A hardware check was performed and was within specifications.The investigation did not identify a product issue.The issue is consistent with incorrect pre-analytic sample handling.
Additional Manufacturer Narrative
The customer provided additional information in relation to the 9 complained patient samples.Refer to the attachment for the patient data, including relevant test data for some of the samples.

• Brand Name: UA2
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16708534
• Report Number: 1823260-2023-01180
• Device Sequence Number: 5821450
• Product Code: KNK
• UDI-Device Identifier: 07613336121580
• UDI-Public: 07613336121580
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K873363
• 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,Followup
• Report Date (Section B): 08/22/2023

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: 09/30/2023
• Device Model Number: UA G2
• Device Catalogue Number: 08058750190
• Device Lot Number: 66468501
• 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: 03/25/2023
• Supplement Date Received by Manufacturer: 05/07/2023; 08/04/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/18/2023; 08/22/2023
• 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