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

Catalog Number	03183807190
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two patient urine samples tested with ua2 (uric acid ver.2) on a cobas 4000 c311.The initial results were reported outside of the laboratory and questioned by the physician as the patients had "normal" serum values.Patient sample 1: the sample initially resulted in a ua2 value of 3.29 mg/dl.The sample was repeated on a cobas c 501 module, resulting in a value of 31.72 mg/dl.Patient sample 2: the sample initially resulted in a ua2 value of 3.0 mg/dl.The sample was repeated on a cobas c 501 module, resulting in a value of 32 mg/dl.
Additional Manufacturer Narrative
Calibration data show that there was a calibration factor change of 10 on (b)(6) 2023, indicating a user error during calibration.The field service engineer cleaned the internal container of the instrument and pipettes.Calibration, quality controls, and patient sample comparison were performed; all results were acceptable.Upon review of the alarm trace, no relevant alarm was observed.The investigation could not identify a product problem.The issue is consistent with a user error during calibration.

• 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: 17309412
• Report Number: 1823260-2023-02234
• Device Sequence Number: 6384116
• Product Code: KNK
• UDI-Device Identifier: 04015630919154
• UDI-Public: 04015630919154
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K922762
• 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): 08/29/2023

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 Catalogue Number: 03183807190
• Device Lot Number: 66109001
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/29/2023
• 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 Age: 49 YR
• Patient Sex: Male