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

Model Number	08057427190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure c 303 analytical unit serial number was (b)(6).The qc was acceptable.The investigation is ongoing.E1 initial reporter telephone number is (b)(6).
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with calcium gen.2 assay on a cobas pure c 303 analytical unit.The initial result was 7.10 mg/dl.The physician questioned the initial result.On (b)(6) 2026, the repeat result after recalibration of the assay was 10.2 mg/dl.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
The field service engineer (fse) found that the sample probe cover was loose.The sample and reagent probes were replaced proactively.The customer had no further issues.The investigation determined that the event was caused by the loose sample cover.A product issue was not found.

• 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: 24485075
• Report Number: 1823260-2026-00736
• Device Sequence Number: 4979872
• Product Code: CHW
• UDI-Device Identifier: 07613336121092
• UDI-Public: 07613336121092
• Combination Product (Y/N): N
• Initial Reporter Country: TD
• 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): 03/23/2026

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 Expiration Date: 03/31/2026
• Device Model Number: 08057427190
• Device Catalogue Number: 08057427190
• Device Lot Number: 850545
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/23/2026
• 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
• Patient Age: 40 YR
• Patient Sex: Female