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

Catalog Number	03183807190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration and qc data provided was acceptable.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable ua2 uric acid ver.2 results for 1 patient from 5 samples on two cobas 8000 cobas c 502 modules, serial numbers (b)(6).The initial results were not reported outside of the laboratory.The customer communicated with the doctor and they stated that the results do not match the patient's clinical status and an interfering substance is suspected.On (b)(6)2023, the ua2 result from analyzer 17e4-01 was 0.0 mg/dl.The sample was repeated on analyzer 17e4-02 and the result was 0.0 mg/dl.A second sample collected from the patient on (b)(6) 2023 also resulted in a ua value of 0.0 mg/dl on analyzer 17e4-01.On (b)(6) 2023, the ua2 results from analyzer 17e4-01 were 0.1 mg/dl and 0.1 mg/dl.The sample was repeated on analyzer 17e4-02 and the result was 0.1 mg/dl.On (b)(6) 2023, the ua2 result from analyzer 17e4-02 was 1.3 mg/dl.On (b)(6) 2023, the ua2 result from analyzer 17e4-02 was 2.7 mg/dl.
Additional Manufacturer Narrative
It was found that the patient takes the medication fasturtec which can cause the degradation of uric acid and lead to falsely low results.The drug manufacturer indicates that samples collected from patients receiving this medication must undergo a specific pre-analytical preparation.This preparation includes cooling the sample after collection and during centrifugation.The cause of the event was determined to be a pre-analytical sample handling issue.The investigation did not identify a product problem.
Additional Manufacturer Narrative
Additional patient results were provided on 27-apr-2023.On (b)(6) 2023, the patient had a uric acid result of 4.2 mg/dl.On (b)(6) 2023, the patient had a uric acid result of 4.7 mg/dl.On (b)(6) 2023, the patient had a uric acid result of 2.0 mg/dl.On (b)(6) 2023, the patient had a uric acid result of 1.8 mg/dl.On (b)(6) 2023, the patient had a uric acid result of 1.6 mg/dl.On (b)(6) 2023, the patient had a uric acid result of 1.8 mg/dl.On (b)(6) 2023, the patient had a uric acid result of 1.6 mg/dl.On (b)(6) 2023, the patient had a uric acid result of 1.8 mg/dl.On (b)(6) 2023, the patient had a uric acid result of 1.7 mg/dl.On (b)(6) 2023, the patient had a uric acid result of 1.4 mg/dl.On (b)(6) 2023, the patient had a uric acid result of 1.5 mg/dl.The investigation is ongoing.

• 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: 16781472
• Report Number: 1823260-2023-01351
• Device Sequence Number: 12510098
• Product Code: KNK
• UDI-Device Identifier: 04015630919154
• UDI-Public: 04015630919154
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K922762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 06/09/2023

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 Catalogue Number: 03183807190
• Device Lot Number: 693815
• 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
• Supplement Date Received by Manufacturer: 04/27/2023; 05/16/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/23/2023; 06/09/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATENOLOL; CYKLOKAPRON; FASTUREC; LYRICA; NOVALGIN; VITAMIN K
• Patient Sex: Male