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

Catalog Number	06407358190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation reviewed the customer's calibration results and there were calibration alarms noted on the date of the event.The investigation did find a successful calibration.The investigation reviewed the customer's qc results and the customer did have level 1 and level 2 results outside of the acceptable range.The investigation reviewed the system's alarm trace and found multiple abnormal aspiration alarms on the date of the event.This is an indication of poor sample quality.The field service engineer checked the instrument and did not find any abnormalities.The customer performed patient comparison testing with other analyzers and had acceptable results.Based on the provided information, the investigation determined the customer's actions of replacing the reagent pack resolved the issue.
Event or Problem Description
The initial reporter received questionable mg2 magnesium gen.2 results for nine patients tested on a cobas 8000 c 702 module serial number (b)(4).Prior to patient testing, the customer confirmed calibration and qc were within the acceptable ranges.The initial magnesium results were reported outside the laboratory.The customer performed qc and had results out of the acceptable ranges.The customer attempted to calibrate the reagent but had failing results.The customer removed the reagent pack and performed repeat testing with the samples on a different cobas 8000 c 702 module.Patient 1's initial magnesium result was 0.8 mg/dl.The patient's repeat magnesium result was 2.0 mg/dl.Patient 2's initial magnesium result was 0.7 mg/dl.The patient's repeat magnesium result was 1.8 mg/dl.Patient 3's initial magnesium result was 0.8 mg/dl.The patient's repeat magnesium result was 2.1 mg/dl.Patient 4's initial magnesium result was 1.2 mg/dl.The patient's repeat magnesium result was 3.2 mg/dl.Patient 5's initial magnesium result was 0.8 mg/dl.The patient's repeat magnesium result was 2.0 mg/dl.Patient 6's initial magnesium result was 0.8 mg/dl.The patient's repeat magnesium result was 2.1 mg/dl.Patient 7's initial magnesium result was 0.9 mg/dl.The patient's repeat magnesium result was 2.2 mg/dl.Patient 8's initial magnesium result was 0.8 mg/dl.The patient's repeat magnesium result was 2.1 mg/dl.Patient 9's initial magnesium result was 1.2 mg/dl.The patient's repeat magnesium result was 3.0 mg/dl.The customer determined the repeat results were correct.

• 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: 14844059
• Report Number: 1823260-2022-01895
• Device Sequence Number: 17341860
• Product Code: JGJ
• UDI-Device Identifier: 04015630930821
• UDI-Public: 04015630930821
• Combination Product (Y/N): N
• 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): 06/28/2022

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: 12/31/2023
• Device Catalogue Number: 06407358190
• Device Lot Number: 62747901
• 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: 06/07/2022
• Initial Report FDA Received Date: 06/28/2022
• 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 Age: 77 YR
• Patient Sex: Female