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	07/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas integra 400 plus serial number is (b)(6).The investigation is ongoing.H3 other text : na.
Event or Problem Description
The initial reporter stated they received discrepant results for three patient samples tested with ua2 (uric acid) on a cobas integra 400 plus system.No questionable results were reported outside of the laboratory.The first measurement of each sample was performed using reagent lot 693815.The second measurement of each sample was performed using a second pack of reagent lot 693815.The third measurement of each sample was performed using reagent lot number 714189.Sample 1 uric acid results: measurement 1 = 0.76 mg/dl measurement 2 = 0.71 mg/dl measurement 3 = 6.05 mg/dl sample 2 uric acid results: measurement 1 = 0.86 mg/dl measurement 2 = 0.91 mg/dl measurement 3 = 7.45 mg/dl sample 3 uric acid results: measurement 1 = 0.46 mg/dl measurement 2 = 0.43 mg/dl measurement 3 = 3.93 mg/dl.
Additional Manufacturer Narrative
Calibration data on the day of the event was ok.Controls were within range on the day of the event.A general reagent issue can be ruled out as calibration and controls are acceptable.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with a deteriorated reagent due to storage or transport.

• 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: 17390063
• Report Number: 1823260-2023-02477
• Device Sequence Number: 20528108
• Product Code: KNK
• UDI-Device Identifier: 04015630919154
• UDI-Public: 04015630919154
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 09/14/2023

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: 11/30/2023
• Device Catalogue Number: 03183807190
• Device Lot Number: 69381501
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 09/14/2023
• 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