MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CALCIUM GEN.2; CALCIUM TEST SYSTEM

Model Number	08057427190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c303 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for calcium gen.2 (ca2) on a cobas c 303 analytical unit.The initial result was 11.2 mg/dl.The repeat result was 7.22 mg/dl.On 02-jun-2025, the result was 7.76 mg/dl.The questionable result was not reported outside of the laboratory.The lower results were believed to be correct.
Additional Manufacturer Narrative
Calibration was last performed on 21-may-2025 with no issues.Qc was acceptable.During a review of the alarm trace data from (b)(6) 2025, six abnormal aspiration alarms were observed.One of these occurred around the time of the initial high result.A field service engineer (fse) and a field application specialist (fas) checked various parts of the instrument and found no issues.Calibration, qc, and precision tests were all acceptable.The customer has had no further issues.Based on the information from the alarm trace data, the investigation determined the event was due to a pre-analytical sample handling issue.

• Brand Name: CALCIUM GEN.2
• Common Device Name: CALCIUM TEST SYSTEM
• 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: 22326947
• Report Number: 1823260-2025-01939
• Device Sequence Number: 18496440
• Product Code: CHW
• UDI-Device Identifier: 07613336121092
• UDI-Public: 07613336121092
• 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): 07/08/2025

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: 01/31/2026
• Device Model Number: 08057427190
• Device Catalogue Number: 08057427190
• Device Lot Number: 83641701
• 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: 07/01/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/08/2025
• 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