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

Model Number	CA GEN.2
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial numbers are (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable calcium gen.2 results for 16 patient samples on two cobas c 503 analytical units.The customer provided an example of discrepant results for 1 patient sample tested.The initial result from analyzer serial number (b)(6) was 39.7 mg/dl accompanied by a flag indicating the value is above the linearity/measuring range of the assay.The customer questioned the high result which prompted them to repeat the sample.The sample was repeated on analyzer serial number (b)(6) and the result was 16 mg/dl.The customer was repeated again on analyzer serial number (b)(6) and the result was 9.4 mg/dl.The next day, the patient had a new sample collected and tested on analyzer serial number (b)(6) and the result was 9.7 mg/dl.The result of 9.4 mg/dl was deemed correct.
Additional Manufacturer Narrative
The root cause of the event was found to be the customer's water supply system not being on bypass while maintenance was being performed.No product problem was identified.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23862464
• Report Number: 1823260-2025-05266
• Device Sequence Number: 15943460
• Product Code: CHW
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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 Model Number: CA GEN.2
• Device Catalogue Number: 05061482190
• Device Lot Number: ASKU
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/28/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown