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

Catalog Number	06407358190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).Two calibrations with 2 different reagent packs were performed on (b)(6) 2024; the signals were much higher than the previous calibration on (b)(6) 2024.Calibrations were performed again on (b)(6) 2024 with one of the same reagent packs and a new reagent pack.Qc was acceptable on (b)(6) 2024.Failing qc was also provided from (b)(6) 2024.There was no qc recovery data for (b)(6) 2024.No issues were identified during a review of the alarm trace data.The customer declined a service visit as the issue was resolved by replacing the reagent and recalibrating.The customer¿s troubleshooting actions resolved the issue.
Event or Problem Description
The initial reporter complained of qc issues and questioned high results for 35 patient samples tested for magnesium (mg2) on a cobas 8000 c 702 module.The customer removed the onboard reagent and recalibrated using the standby reagent.The following are examples of discrepant results for 2 patient samples.Patient 1 initial result was 3.6 mg/dl.The repeat result was 2.1 mg/dl.Patient 2 initial result was 3.4 mg/dl.The repeat result was 2.0 mg/dl.

• 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: 19745564
• Report Number: 1823260-2024-02039
• Device Sequence Number: 6491856
• Product Code: JGJ
• UDI-Device Identifier: 04015630930821
• UDI-Public: 04015630930821
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2024

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 06407358190
• Device Lot Number: 76914901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 07/15/2024
• 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 Age: 63 YR
• Patient Sex: Male