MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALBT2 TINA-QUANT ALBUMIN GEN.2; ALBUMIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number	04469658190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c502 module serial number was (b)(6).Errors were observed during a review of the calibration trace data.The customer did not provide any additional data or information for investigation.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter complained of discrepant results for 2 patient urine samples tested for albt2 tina-quant albumin gen.2 (albt2) on a cobas 8000 c 502 module.Patient 1 initial result was 27.3 mg/l.The repeat result was 0.5 mg/l.Patient 2 initial result was 191.3 mg/l.The repeat result was 12.0 mg/l.It is not known which results were believed to be correct.No questionable results were reported outside of the laboratory.

• Brand Name: ALBT2 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20844122
• Report Number: 1823260-2024-03515
• Device Sequence Number: 19815450
• Product Code: DCF
• UDI-Device Identifier: 04015630920587
• UDI-Public: 04015630920587
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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: 02/28/2026
• Device Catalogue Number: 04469658190
• Device Lot Number: 80065801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/04/2024
• 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