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

Catalog Number	06407358190
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	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The qc was acceptable.The field service representative replaced the gear pump, flushed out the naoh with hot water and acid, replaced the syringe seals, replaced the vacuum diaphragms, checked the rinse consumption from the syringes, and checked the naoh concentration.He performed tests with acceptable results.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable magnesium gen.2 results for 1 patient sample on a cobas 8000 c702 module.The initial result was 2.67 mg/dl.The sample was repeated on another module, and the results were 2.11 mg/dl, 2.02 mg/dl, and 2.07 mg/dl.The repeated results were believed to be correct.The sample was repeated because the customer has had ongoing issues.
Additional Manufacturer Narrative
The investigation was unable to determine a specific root cause and did not identify a product problem.The issue appeared to be resolved by the service actions.

• Brand Name: MAGNESIUM GEN.2
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• 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: 21917475
• Report Number: 1823260-2025-01290
• Device Sequence Number: 9022494
• Product Code: JGJ
• UDI-Device Identifier: 04015630930821
• UDI-Public: 04015630930821
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: 08/31/2026
• Device Catalogue Number: 06407358190
• Device Lot Number: 839001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/27/2025
• 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