MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MAGNESIUM GEN.2; PHOTOMETRIC MAGNESIUM ASSAY

Catalog Number	08058016190
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	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure c 303 analytical unit serial number was (b)(6).The field service engineer adjusted the rinse station alkaline level, replaced the reaction cells, and decontaminated the sample and reagent probes.Calibration, qc, a hardware check, and precision were performed successfully.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable magnesium gen.2 results from the cobas pure c 303 analytical unit.The initial result was 3.11 mg/dl.The repeat result was 2.1 mg/dl.
Additional Manufacturer Narrative
The investigation determined the service actions resolved the issue.

• Brand Name: MAGNESIUM GEN.2
• Common Device Name: PHOTOMETRIC MAGNESIUM ASSAY
• 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: 21630898
• Report Number: 1823260-2025-00765
• Device Sequence Number: 8266329
• Product Code: JGJ
• UDI-Device Identifier: 07613336121412
• UDI-Public: 07613336121412
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K983416
• 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): 04/17/2025

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 Catalogue Number: 08058016190
• Device Lot Number: 805791
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/17/2025
• 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