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

Model Number	08057427190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable results from the cobas c 503 analytical unit.The customer alleged there was interference from the patient's medications.This medwatch is for the calcium gen.2 assay.Refer to the medwatch with a1 patient identifier (b)(6) for the magnesium gen.2 assay.Patient 1: the initial magnesium gen.2 result was 0.149 mg/dl, and the initial calcium gen.2 result was - 0.101 mg/dl.This patient was being treated with isoprinosine.The sample was repeated using a cobas c501, and the magnesium result was 0.544 mg/dl.The calcium result was -0.0693 mg/dl.Patient 2: the initial magnesium result was 0.218 mg/dl, and the initial calcium was 1.18 mg/dl.This patient was being treated with cortizon.The sample was repeated using a cobas c501, and the magnesium result was 0.214 mg/dl.The questionable results were not reported outside of the laboratory.
Additional Manufacturer Narrative
Additional information was provided clarifying that patient 1 occurred on (b)(6) 2025.Medwatch field b3 date of event was updated.Patient 2 occurred on (b)(6) 2025.
Additional Manufacturer Narrative
A general reagent problem could be excluded because calibration and quality control were acceptable.Due to the limited information provided, the investigation was unable to determine a specific root cause.There was no product problem identified.

• 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: 23679878
• Report Number: 1823260-2025-04896
• Device Sequence Number: 9715830
• Product Code: CHW
• UDI-Device Identifier: 07613336121092
• UDI-Public: 07613336121092
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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,Followup
• Report Date (Section B): 02/23/2026

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: 894309
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 02/05/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/22/2025; 02/23/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT 1: ISOPRINOSINE.; PATIENT 2: CORTIZON.
• Patient Sex: Unknown