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

Catalog Number	03183807190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c501 analyzer is (b)(6).The customer changed the reagent pack and a patient sample processed with the pack had a correct result.No further issues were observed since changing the pack.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for three patient samples tested with uric acid ver.2 on a cobas 6000 c501 module.The first sample initially resulted in a uric acid value of 0.6 mg/dl.The sample was repeated on a second analyzer, resulting in a value of 7.69 mg/dl.The second sample initially resulted in a uric acid value of 0.5 mg/dl.The sample was repeated on a second analyzer, resulting in a value of 5.41 mg/dl.The third sample initially resulted in a uric acid value of 0.5 mg/dl.The sample was repeated on a second analyzer, resulting in a value of 5.03 mg/dl.
Additional Manufacturer Narrative
Calibration was acceptable.Controls run on the day of the event were acceptable.It was determined that the customer does not run controls on standby reagent packs.Standby reagent packs may come into use during routine operation.The investigation could not identify a product problem.The cause of the event could not be determined.Medwatch field d4 has been updated.

• 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: 19557771
• Report Number: 1823260-2024-01803
• Device Sequence Number: 4734257
• Product Code: KNK
• UDI-Device Identifier: 04015630919154
• UDI-Public: 04015630919154
• Combination Product (Y/N): Y
• Initial Reporter Country: RO
• 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): 07/11/2024

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: 09/30/2024
• Device Catalogue Number: 03183807190
• Device Lot Number: 75303401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/11/2024
• 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 Sex: Unknown