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

Model Number	CA GEN.2
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable result calcium gen.2 from the cobas 6000 c (501) module.The initial result was 1.38 mg/dl, and the repeat result from a different c501 analyzer was 8.34 mg/dl.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
The cobas 6000 c (501) module serial number is (b)(6).The investigation is still ongoing.
Additional Manufacturer Narrative
A field service engineer (fse) checked all of the pressures and water levels and performed mechanical function checks on the system.The system passed a hardware check by test performance, a calcium precision test, calibration, and qc.No root cause was found however the instrument performance was verified and the investigation determined that the service action resolved the issue.

• 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: 21264879
• Report Number: 1823260-2025-00265
• Device Sequence Number: 15839303
• Product Code: CHW
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/11/2025

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: 11/30/2025
• Device Model Number: CA GEN.2
• Device Catalogue Number: 05061482190
• Device Lot Number: 821334
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/11/2025
• 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 Age: 63 YR
• Patient Sex: Male