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

Model Number ADVIA CHEMISTRY LIPASE REAGENTS

Device Problem Insufficient Information (3190)

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

Event Date 03/23/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the falsely high lipase result on the one patient sample is unknown.Siemens healthcare is investigating the issue.

Event Description

The customer has obtained a falsely high result on one patient sample for lipase assay on the advia chemistry 1800 instrument when using reagent lot 354459.The sample was run in a panel with other lipid tests when the falsely high result was obtained the sample was repeated and run on its own and the value was lower.The initial high result was not reported to the physician(s).It is unknown if the repeat value was reported to the physician(s).There were no reports of patient intervention or adverse health consequences due to the falsely high result for lipase.

Manufacturer Narrative

Additional information (4/28/2016): a siemens headquarters support center (hsc) representative evaluated the instrument files and confirmed that the contamination avoidance and detergent settings on the instrument were correct per assay instructions.A siemens field service engineer (fse) visited the customer site and evaluated the instrument.The fse changed the dilution tray, reaction tray cuvettes, inspected reagent 1 probe and reagent 2 probe and mixer paddles.Reagent 1 probe was replaced by the fse.The customer has notified siemens that they will be using the lipase assay on its own and will not be running it with other assays.The cause of the falsely high result for lipase is unknown.

• 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: 5590192
• MDR Text Key: 43203164
• Report Number: 2432235-2016-00192
• 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: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• 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
• Device Lot Number: .354459
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1