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	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable calcium gen.2 result from the cobas 8000 cobas c 502 module.The initial result was 65.51 mg/l, and the repeat result was 92.75 mg/l.
Additional Manufacturer Narrative
The cobas 8000 cobas c 502 module serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Both qc and calibration were passing before the event occurred; therefore, a general reagent issue is not present.The investigation determined that there was no product issue found.

• 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: 22318202
• Report Number: 1823260-2025-01928
• Device Sequence Number: 15656492
• Product Code: CHW
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/17/2025

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: 07/31/2026
• Device Model Number: CA GEN.2
• Device Catalogue Number: 05061482190
• Device Lot Number: 869544
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/17/2025
• 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