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

Catalog Number	08058016190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The qc recovery data provided was acceptable.The field service engineer (fse) found that the system was contaminated.The fse exchanged the water supply and replaced the affected cuvette segment.A precision test was performed successfully.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable magnesium gen.2 results for several patient samples on a cobas c 303 analytical unit.The customer provided an example of discrepant results for 1 patient plasma sample.The customer was prompted to repeat the patient samples as they were accompanied by critical flags applied by the middleware.The initial magnesium result was 3.9 mg/dl.The repeat result was 1.8 mg/dl.The repeat result was deemed correct.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2025.The alarm trace did not contain a conspicuous event.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23057774
• Report Number: 1823260-2025-02884
• Device Sequence Number: 8617887
• Product Code: JGJ
• UDI-Device Identifier: 07613336121412
• UDI-Public: 07613336121412
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 86016401
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/16/2025
• 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