MAUDE Adverse Event Report: ROCHE DIAGNOSTICS Tina-quant Albumin Gen.2; Albumin immunological test system

Catalog Number	08056722190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 503 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient urine sample tested with the tina-quant albumin gen.2 assay and creatinine assay on a cobas c 503 analytical unit.The sample initially resulted in the following values: microalbumin = 8.77 mg/dl.Creatinine = 24.80.The creatinine unit of measure is unknown.The sample was repeated, resulting in the following values: microalbumin = 8.74 mg/dl.Creatinine = 18.60.The sample was diluted 1:10 and repeated, resulting in a microalbumin value of 45.10 mg/dl.The sample was also diluted 1:3 and repeated, resulting in a microalbumin value of 19 mg/dl.The sample was repeated two more times, resulting in microalbumin values of 8.68 mg/dl and 8.43 mg/dl.The sample was repeated using decreased sample volume, resulting in a microalbumin value of 47.2 mg/dl.The sample was diluted 1:11 and repeated on (b)(6) 2026, resulting in a microalbumin result of 47.4 mg/dl.

• 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--045
• MDR Report Key: 25677014
• Report Number: 1823260-2026-02642
• Device Sequence Number: 4797688
• Product Code: DCF
• UDI-Device Identifier: 07613336120965
• UDI-Public: 07613336120965
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101203
• Number of Events Summarized: 1
• Summary Report (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): 09/21/2026

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: 08056722190
• Device Lot Number: 944585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 07/02/2026; 08/31/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 07/28/2026; 09/21/2026
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATORVASTATIN; CALCIFEDIOL; ESCITALOPRAM; FOLIC ACID; FRESUBIN NEUTRAL THICKENER; INCONTINENCE ABSORBENTS; MESALAZINE; OMEPRAZOLE; SERENOA REPENS; SODIUM VALPROATE; ULTIBRO BREEZHALER; VENTOLIN
• Patient Age: 72 YR
• Patient Sex: Male