MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT ALBUMIN GEN.2; ALBUMIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number	08056722190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable tina-quant albumin gen.2 (miroalbumin) results for urine samples from the cobas c 503 analytical unit.The samples were repeated on the same analyzer and then another cobas c 503 analytical unit.Sample (b)(6) initial result was 98.6 mg/l, and the repeat results were 20.8 mg/l and 3.3 mg/dl with a data flag (reported as <12.0 mg/l).Sample (b)(6) initial result was 32.4 mg/l, and the repeat results were 5.28 mg/l with a data flag (reported as <12.0 mg/l) and 4.12 mg/l with a data flag (reported as <12.0 mg/l).The repeat results from the other analyzer were believed to be correct.
Additional Manufacturer Narrative
The field service engineer found there was an issue with the reagent pack.He cleaned and adjusted the reagent probe, as a white crust was present.The customer loaded a new reagent pack and performed calibration, qc, and precision testing.Based on the information provided, the investigation was unable to determine a specific root cause.The investigation determined the issue was resolved by the service and customer actions.

• Brand Name: TINA-QUANT ALBUMIN GEN.2
• Common Device Name: ALBUMIN IMMUNOLOGICAL 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22095314
• Report Number: 1823260-2025-01630
• Device Sequence Number: 8059843
• Product Code: DCF
• UDI-Device Identifier: 07613336120965
• UDI-Public: 07613336120965
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: 12/31/2025
• Device Catalogue Number: 08056722190
• Device Lot Number: 78834501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/17/2025
• 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 Age: 68 YR
• Patient Sex: Female