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

Catalog Number	05167043190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the first c 702 analyzer is (b)(6) and the serial number of the second c 702 analyzer is (b)(6).The provided calibration data showed some degree of calibration failures.The provided quality control data showed some qc recovery issues.A hardware check test was performed and showed issues with precision for another test.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient cerebrospinal fluid sample tested with albt2 tina-quant albumin gen.2 on two cobas 8000 c702 module analyzers.The sample initially resulted in an albumin value of 378 mg/l when tested on the first c 702 analyzer.The sample was repeated on the second c 702 analyzer, resulting in a value of 225 mg/l.The 225 mg/l value was reported to the physicians.
Additional Manufacturer Narrative
Calibration data showed some degree of calibration failures.Quality control data showed recovery issues.Hardware check data showed some issues with pipetting precision and mixing.Alarm trace data showed pressure sensor errors and failed sample probe wash errors.The sample probes were exchanged.The investigation could not identify a specific root cause.The issue is consistent with a mixture of hardware issues as well as sample clot issues.

• 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: 21085254
• Report Number: 1823260-2025-00040
• Device Sequence Number: 17836081
• Product Code: DCF
• UDI-Device Identifier: 04015630924899
• UDI-Public: 04015630924899
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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,Followup
• Report Date (Section B): 02/21/2025

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: 07/31/2025
• Device Catalogue Number: 05167043190
• Device Lot Number: 75810301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/21/2025
• 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 Sex: Unknown