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

Catalog Number	06481647190
Medical Device Problem Codes	Mechanical Problem (1384); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mg2 reagent lot number was 69798601 with an expiration date of 30-sep-2024.Before the event, calibration and qc were performed and they were not acceptable.After calibration and qc were repeated and were successful, the patient's sample was then tested.The field service engineer (fse) checked the cuvette usage records and the wash rinse unit and found no abnormalities.He observed white powder with worn cuvettes on the upper and lower parts of the cover plate.The fse cleaned the white powder and adjusted the fluid volume of the rinse station.The white powder was most likely the abrasion of the cell material by the metal cover.The root cause was due to the presence of the white powder.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's sample tested with magnesium gen.2 (mg2) assay on a cobas 6000 c501 analyzer.Initial result: 2.01 mmol/l.No questionable result was released outside of the laboratory as the result did not match the patient's clinical diagnosis.And the sample was repeated.Rerun result: 0.83 mmol/l.
Additional Manufacturer Narrative
The field service engineer checked the analyzer and adjusted the cuvette rinse station.He also cleaned the black water tank.The root cause was consistent with a maintenance issue.The service actions (adjusting the cuvette rinse station and cleaning the black water tank) resolved the issue.No further issues were reported afterward.

• 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 46250-0457
• MDR Report Key: 17988977
• Report Number: 1823260-2023-03398
• Device Sequence Number: 15428789
• Product Code: JGJ
• UDI-Device Identifier: 04015630929818
• UDI-Public: 04015630929818
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K954992
• 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): 12/06/2023
• 2 Devices were Involved in the Event: 1 2

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: 09/30/2024
• Device Catalogue Number: 06481647190
• Device Lot Number: 69798601
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/06/2023
• 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 Age: 14 YR
• Patient Sex: Male