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

Catalog Number 06407358190

Device Problem Non Reproducible Results (4029)

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

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas 8000 c702 module is 15c7-08.The investigation is ongoing.

Event Description

The initial reporter received questionable mg2 magnesium gen.2 results from five patient samples tested on the cobas 8000 c702 module.It is unknown if the initial results were reported outside of the laboratory.The reporter suspects imprecision.The reporter was able to provide the following examples of discrepant results: (b)(6).The patient sample was run on line 2 of the module.The initial result was 0.68 mmol/l.The first repeat result was 0.47 mmol/l.The second repeat result was 0.42 mmol/l.(b)(6).The patient sample was run on line 2 of the module.The initial result was 1.15 mmol/l.The first repeat result was 0.79 mmol/l.The second repeat result was 0.81 mmol/l.(b)(6).The initial result from line 2 was 0.28 mmol/l.The first repeat result from line 2 was 0.55 mmol/l.The second repeat result from line 1 was 0.31 mmol/l.

Manufacturer Narrative

Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• 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
• MDR Report Key: 18085267
• MDR Text Key: 327613841
• Report Number: 1823260-2023-03540
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 04015630930821
• UDI-Public: 04015630930821
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K983416
• 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: 02/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 06407358190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/15/2024
• 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