MAUDE Adverse Event Report: TECAN AUSTRIA GMBH MAGELLAN TRACKER; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number 30070473

Device Problems False Negative Result (1225); Application Program Problem: Parameter Calculation Error (1449)

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

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Magellan is a universal reader control and data reduction software that allows users to define programs for analyzing data generated from microplate tests using tecan measuring devices.A kit manufacturer developed a magellan software method for a specific assay for their customers to use.Magellan instructions for use require that the operating authority must validate all methods to ensure the safety of the results for clinical diagnostic applications.The user defined magellan method contained a program step, that evaluates samples as "positive", "negative" or "borderline".Under a specific chain of events the software used default settings instead of user defined input parameters.The user did not detect this error as the verification of the method was incomplete.All input measurement data and calculated concentration values were correct.Only the user defined evaluation of the data contained an error.A review of complaints since 2009 showed that this was the first reported complaint in relation to this issue.Investigation conclusion is a validation of the method would have detected the error.A workaround is available enabling the kit manufacturer to resolve the issue.In an abundance of caution since potentially incorrect clinical diagnostic results were released, a mdr report is filed.

Event Description

A customer reported that incorrect assessments of measured results were released.The incident occurred in (b)(6).The customer did not report death, serious injury, misdiagnosis or inappropriate treatment in relation to this issue.The user was using a user-defined method in the reader control and data reduction software.The user realized that one parameter of the method was not working properly.As a results, there was the potential of incorrect results being released.In an abundance of caution, reporting is required as incorrect results were released.

• Brand Name: MAGELLAN TRACKER
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): TECAN AUSTRIA GMBH; untersbergstr. 1a; groedig, 5082 ; AU 5082
• Manufacturer (Section G): TECAN AUSTRIA GMBH; untersbergstr. 1a; groedig, 5082 ; AU 5082
• Manufacturer Contact: hanna ebner-kalss ; untersbergstr. 1a; groedig, 5082 ; AU 5082
• MDR Report Key: 12588320
• MDR Text Key: 276576465
• Report Number: 3002710220-2021-00001
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 30070473
• Device Lot Number: 7.1.7.3 (SP1)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1