MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MG2; PHOTOMETRIC METHOD, MAGNESIUM

Catalog Number	06407358190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 c702 module is 15c7-08.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable mg2 magnesium gen.2 results from five patient samples tested on the cobas 8000 c702 module.It is unknown if the initial results were reported outside of the laboratory.The reporter suspects imprecision.The reporter was able to provide the following examples of discrepant results: (b)(6).The patient sample was run on line 2 of the module.The initial result was 0.68 mmol/l.The first repeat result was 0.47 mmol/l.The second repeat result was 0.42 mmol/l.(b)(6).The patient sample was run on line 2 of the module.The initial result was 1.15 mmol/l.The first repeat result was 0.79 mmol/l.The second repeat result was 0.81 mmol/l.(b)(6).The initial result from line 2 was 0.28 mmol/l.The first repeat result from line 2 was 0.55 mmol/l.The second repeat result from line 1 was 0.31 mmol/l.
Additional Manufacturer Narrative
Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: MG2
• 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: 18085267
• Report Number: 1823260-2023-03540
• Device Sequence Number: 6788920
• Product Code: JGJ
• UDI-Device Identifier: 04015630930821
• UDI-Public: 04015630930821
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 02/15/2024

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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