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 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating the issue.The cause of the discordant, falsely elevated lipase result on one patient sample is unknown.

Event Description

The customer obtained discordant, falsely elevated lipase result on one patient sample on an advia chemistry xpt instrument, while using reagent kit lot 401119.The customer has a setting on the instrument to auto repeat the results greater than 35 u/l.The first repeat run was auto repeat and the second repeat run was performed manually, both resulting lower.The discordant result was not reported to the physician(s).The repeat results were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated result.

Manufacturer Narrative

The initial mdr 2432235-2017-00210 was filed on march 24, 2017.Additional information (04/07/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided by the customer.There were no reports of quality control issues or issues with other patient samples.The hsc specialist stated that the advia chemistry xpt contamination avoidance settings are found in the customer bulletin 10815606, rev.E, issued 2017-02.The hsc specialist recommended that the customer ensures the contamination avoidance settings provided within this document matches what is in the instrument and that the process order is configured correctly.The cause of the discordant, falsely elevated lipase result on one patient sample is unknown.The instrument is performing as expected.No further evaluation of device is required.

Manufacturer Narrative

The initial mdr 2432235-2017-00210 was filed on march 24, 2017.The first supplemental mdr 2432235-2017-00210_s1 was filed on may 4, 2017.Additional information (05/24/2017): a siemens customer care center specialist followed the siemens headquarters support center specialist's recommendations and verified that the advia chemistry xpt contamination avoidance settings at the customer site were in accordance with the customer bulletin 10815606, rev.E, issued 2017-02.

• Brand Name: ADVIA CHEMISTRY LIPASE REAGENTS
• Type of Device: ADVIA CHEMISTRY LIPASE REAGENTS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD. (REGISTRATION # 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: 6431699
• MDR Text Key: 70796083
• Report Number: 2432235-2017-00210
• Device Sequence Number: 1
• Product Code: CHI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 06/13/2017

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 Model Number: ADVIA CHEMISTRY LIPASE REAGENTS
• Device Catalogue Number: 10311896
• Device Lot Number: 401119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/04/2017; 06/13/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1