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

Model Number	08057427190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration data was within the specifications.Gel particles were found in the sample probe.The field service engineer exchanged the sample probe.The investigation did not identify a product problem.The cause of the event was due to a preanalytic issue (gel particles were found in the sample probe) at the customer site.Preanalytics are within the customer's responsibility.
Event or Problem Description
We received an allegation about discrepant results for 1 patient plasma sample tested with calcium gen.2 (ca2) assay on a cobas c503 analytical unit when compared to a different cobas c503 analytical unit.Initial result: 3.12 mmol/l.1st repeat result: 2.54 mmol/l (tested with automatic rerun).2nd repeat result: 2.56 mmol/l (tested on another c503).No questionable result was reported outside the laboratory.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The ca2 reagent expiration date was not provided.The cobas c503 analytical unit serial number was (b)(6).Qc was within the assigned ranges on the day of the event.The field service engineer noted a large number of abnormal aspiration (sample pipetter s1) alarms.The investigation is ongoing.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21180742
• Report Number: 1823260-2025-00178
• Device Sequence Number: 8537610
• Product Code: CHW
• UDI-Device Identifier: 07613336121092
• UDI-Public: 07613336121092
• 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): 01/30/2025

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: 08057427190
• Device Catalogue Number: 08057427190
• Device Lot Number: 836417
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 01/30/2025
• 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: 7 DA
• Patient Sex: Male