MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CHEMISTRY LIPASE REAGENTS

Model Number ADVIA CHEMISTRY LIPASE REAGENTS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

The customer had received the customer bulletin sent out in september 2015 for lipase, with updates to the contamination avoidance settings in the system software.A siemens field service engineer (fse) along with siemens regional support center (rsc) reviewed the software settings at the customer site.It was noticed that the new setting and the analysis order were input incorrectly into the software.The errors were corrected and the updated information was added to the software settings.The cause of the falsely high result for lipase was due to the incorrect settings in the software.The system is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer has obtained a falsely high result on one patient sample for the lipase assay on the advia chemistry 1800 instrument when using reagent lot 339018.There were no reports of patient intervention or adverse health consequences due to the falsely high result for lipase.

• Brand Name: ADVIA CHEMISTRY LIPASE REAGENTS
• Type of Device: ADVIA CHEMISTRY LIPASE REAGENTS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORES LTD. (REG# 8020890); 55 diamond road; crumlin; co. antrim, BT29 4QY; UK BT29 4QY
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 5277046
• MDR Text Key: 33010501
• Report Number: 2432235-2015-00568
• Device Sequence Number: 1
• Product Code: CHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/16/2015

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: No Information
• Device Model Number: ADVIA CHEMISTRY LIPASE REAGENTS
• Device Catalogue Number: 10311896
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1