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

Model Number	CA GEN.2
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ca2 reagent expiration date was not provided.The c311 system serial number was (b)(6).The qc was within the assigned ranges on the day of the event.The field service engineer found that the alarm trace showed multiple alarms that the water level was too low, and the blank tube for the rinse station was contaminated.He decontaminated the sample probe and cleaned the water tank, as it had some impurities.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with calcium gen.2 (ca2) assay on a cobas 4000 c311 stand alone system.Initial result: 12.9 mg/dl (tested on c311).The patient questioned the initial result, and the sample was repeated.1st repeat result: 13.9 mg/dl (tested on cobas integra analyzer).On (b)(6) 2025, the sample was repeated: 2nd and 3rd repeat results were 8.9 mg/dl and 8.8 mg/dl (tested on c311).4th repeat result: 9.3 mg/dl (tested on cobas integra analyzer).5th repeat result: 8.9 mg/dl (tested on cobas integra analyzer and processed after performing a new calibration).The repeat results obtained on (b)(6) 2025 were deemed to be correct.
Additional Manufacturer Narrative
The field service engineer checked the gear pump pressure and the main pump pressure.He performed hardware checks that confirmed the instrument was operating within specifications.The investigation was unable to determine a specific root cause.The issue was consistent with contamination of the rinse station, a contaminated sample probe, a dirty water tank, and pre-analytical handling issues leading to sample-related discrepancies.

• 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: 22079023
• Report Number: 1823260-2025-01591
• Device Sequence Number: 15631189
• Product Code: CHW
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 06/26/2025

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
• Device Lot Number: 82133401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/26/2025
• 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