MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 ANALYZER

Model Number ADVIA 1800

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

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

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

The falsely elevated lipase result was obtained from an advia 1800 instrument which also runs the triglyceride assay.The triglyceride assay is not run on the advia 1800 instrument from which the lower lipase result was obtained.A siemens customer care center (ccc) specialist stated that the avoidance settings to prevent interference between the triglyceride assay and the lipase assay had been implemented on the advia 1800 instruments.The customer is continuing to measure lipase on the advia 1800 instrument that does not run the triglyceride assay.The cause of the discordant, falsely elevated lipase result is unknown.Siemens is investigating this issue.

Event Description

A patient sample was evaluated for lipase on two advia 1800 instruments.The lipase result from one instrument was falsely elevated compared to the result from the other instrument.The discordant, falsely elevated lipase result as well as the lower lipase result were not reported to physician(s).The lower lipase result was in alignment with the clinical picture and medical history of the patient.There are no known reports of patient intervention due to the falsely elevated lipase result.There are no known reports of a delay in administering treatment or medical intervention to the patient due to the falsely elevated lipase result.

Manufacturer Narrative

The initial mdr 2432235-2017-00293 was filed on april 26th 2017.Additional information (06/14/2017): a siemens headquarter support center (hsc) specialist reviewed the information and stated that there is no issue with the assay or the reagent lot, but the issue could be related to the instrument.The contamination avoidance settings and analysis order on the instrument has not been obtained from the customer.The hsc specialist is not able to investigate this issue further without this information.The cause of the discordant, falsely elevated lipase result is unknown.

• Brand Name: ADVIA 1800 ANALYZER
• Type of Device: ADVIA 1800 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; registration # 3003637681; 3-1-2 musashino akishima; tokyo, 96-85 58; JA 96-8558
• Manufacturer Contact: devyani chaudhuri ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242637
• MDR Report Key: 6522555
• MDR Text Key: 74069266
• Report Number: 2432235-2017-00293
• Device Sequence Number: 0
• Product Code: CHI
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 1800
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2017
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2017
• 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: Reuse
• Patient Sequence Number: 1