MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALBUMIN GEN.2; BROMCRESOL GREEN DYE-BINDING, ALBUMIN

Catalog Number	03183688122
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 c (501) module serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of 10 questionable albumin gen.2 results from the cobas 6000 c (501) module.Only the data for 2 of the patients were provided, and are a reportable malfunction.Patient 1's initial result was 0.42 g/dl, and the repeat result from another instrument was 4.22 g/dl patient 2's initial result was 0.47 g/dl, and the repeat result from another instrument was 4.78 g/dl.The repeat results were deemed to be correct.The initial results were repeated because the doctor or technician questioned the critical results.
Additional Manufacturer Narrative
A field service engineer (fse) determined that the reagent pack needed to be recalibrated.The fse checked the probe alignments, the gear pump pressure was adjusted, there were no leaks found, and the rinse head mechanism nozzles were checked and were okay.Qc and precision were completed and passed.The investigation determined that the service action resolved the issue.

• Brand Name: ALBUMIN GEN.2
• Common Device Name: BROMCRESOL GREEN DYE-BINDING, ALBUMIN
• 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: 22676057
• Report Number: 1823260-2025-02364
• Device Sequence Number: 12996182
• Product Code: CIX
• UDI-Device Identifier: 04015630918898
• UDI-Public: 04015630918898
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K033009
• 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): 08/20/2025

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 Catalogue Number: 03183688122
• Device Lot Number: 841248
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/20/2025
• 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