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

Catalog Number 06481647190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The investigation is ongoing.

Event Description

There was an allegation of questionable mg2 magnesium gen.2 results for 1 patient sample on a cobas integra 400 plus module.The initial result was 3.2 mg/dl with flag.The nurse questioned the result and the sample was repeated.The sample was repeated the next day and the result was 2.0 mg/dl.The sample was also repeated on another integra 400 plus analyzer and the result was 2.1 mg/dl.The repeat results were deemed correct.

Manufacturer Narrative

Section d product information has been updated, as well as g1 manufacturing site and g4.Calibration was last performed on 30-aug-2023.The qc recovery data provided was acceptable.The alarm trace showed clot detection, cuvette buffer slide empty, and not enough fluid alarms.The field service engineer (fse) found that the waste pump was defective.The fse replaced the waste pump, replaced a cracked splash guard on the sample probe wash station, primed the system, and performed precision testing.The customer performed calibration and qc successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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 INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18162925
• MDR Text Key: 328433048
• Report Number: 1823260-2023-03659
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 04015630929818
• UDI-Public: 04015630929818
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2024
• 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: 10/25/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Male