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

Model Number	C501
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter complained of questionable results for multiple patients tested for mg2 on a cobas 6000 c (501) module.Discrepant results were provided for 1 patient sample.The initial result was 3.9 mg/dl.This result was reported outside of the laboratory where it was questioned.The repeat result was 2.2 mg/dl.The repeat result was believed to be correct.The mg2 reagent lot number was 596601.The expiration date was not provided.
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).No pre-analytic issues were identified.Calibration was last performed on (b)(6) 2022 and was acceptable.Qc was acceptable.There was no indication for a performance issue of the reagent.No issues were identified during a review of the alarm trace data.The field service engineer (fse) found the reagent pack was contaminated and replaced it.The customer ran precision testing along with a patient correlation.All results were reproducible and precision results were within specification.The customer has had no further issues since the service visit.The investigation determined the service actions resolved the issue.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13929974
• Report Number: 1823260-2022-00880
• Device Sequence Number: 5388262
• Product Code: JGJ
• UDI-Device Identifier: 04015630929818
• UDI-Public: 04015630929818
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022
• 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 Model Number: C501
• Device Catalogue Number: 06481647190
• Device Lot Number: 596601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 05/09/2022
• 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