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

Catalog Number 06481647190

Device Problems Mechanical Problem (1384); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 326317342
• Report Number: 1823260-2023-03398
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K954992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 06481647190
• Device Lot Number: 69798601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Male