MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CALCIUM GEN.2; TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM

Model Number	CA GEN.2
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for an unspecified number of patient samples tested with calcium gen.2 on a cobas 8000 c 502 module.The customer noted the issue was previously resolved by replacing a deionizer filter, but it has occurred again.The exact values were not provided.The initial values were not in line with the previous history of the patients.The customer stated the samples were repeated on a different instrument.The rerun results were halved when compared to the initial results.
Additional Manufacturer Narrative
The serial number of the c 502 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: CALCIUM GEN.2
• Common Device Name: TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM
• 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: 21729740
• Report Number: 1823260-2025-00938
• Device Sequence Number: 14490087
• Product Code: CHW
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K113521
• 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): 04/30/2025

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 Model Number: CA GEN.2
• Device Catalogue Number: 05061482190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 04/30/2025
• 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