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

Catalog Number	06407358190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number is (b)(6).It was determined that the qc ranges were not adjusted properly.The supervisor reviewed the qc ranges and adjusted them.Verification for calibration and qc was performed.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable magnesium gen.2 results from the cobas 8000 c702 module.Sample 1's initial result was 0.8 mg/dl accompanied by a data flag, and the repeat result was 1.7 mg/dl.Sample 2's initial result was 0.9 mg/dl accompanied by a data flag, and the repeat result was 1.7 mg/dl.Sample 3's initial result was 0.8 mg/dl accompanied by a data flag, and the repeat result was 2.1 mg/dl.The repeat results were deemed to be correct.The initial results were questioned because they were flagged as a critical result.
Additional Manufacturer Narrative
The case is closed as the customer adjusted their qc range and resolved the issue.No product issue was found.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22043383
• Report Number: 1823260-2025-01532
• Device Sequence Number: 8908075
• Product Code: JGJ
• UDI-Device Identifier: 04015630930821
• UDI-Public: 04015630930821
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/22/2025

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: 06407358190
• Device Lot Number: 85276001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 05/22/2025
• 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