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

Model Number	CA GEN.2
Medical Device Problem Codes	High Test Results (2457); High Readings (2459); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter establishment name: (b)(6).The analyzer's serial number is (b)(6).It was noted that the water quality from the water system in the takes was poor.The guard filters were changed and the water quality improved.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable calcium gen.2 results for 19 patient samples on a cobas 8000 c 702 module.Examples for 3 of the alleged patient samples: patient 1: the initial result was 3.38 mmol/l and the repeated result was 2.47 mmol/l.Patient 2: the initial result was 3.23 mmol/l and the repeated result was 2.32 mmol/l.Patient 3: the initial result was 3.14 mmol/l and the repeated result was 2.26 mmol/l.
Additional Manufacturer Narrative
The investigation determined the issue was due to poor water quality.The investigation did not identify a product problem.

• 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: 21286931
• Report Number: 1823260-2025-00308
• Device Sequence Number: 7961552
• Product Code: CHW
• UDI-Device Identifier: 04015630924936
• UDI-Public: 04015630924936
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/20/2025

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 Model Number: CA GEN.2
• Device Catalogue Number: 05168449190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 02/20/2025
• 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