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

Model Number ADVIA 1800 ANALYZER

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

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

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer care center (ccc) specialist remotely confirmed that the calibration and quality control results were within range.No other discordant results were obtained by the customer.The cause of the discordant, falsely elevated lipase result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely elevated lipase result was obtained on one patient sample on an advia chemistry 1800 instrument while using reagent lot 383921.The initial result was flagged by the instrument as a high result.The same sample was repeated on the same instrument and on another advia chemistry 1800 instrument, resulting lower.The initial discordant result was not reported to physician(s).One of the repeat results was reported to physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated lipase result.There are no known reports of a delay in administering treatment or medical intervention to the patient due to the discordant, falsely elevated lipase result.

Manufacturer Narrative

The initial mdr 2432235-2017-00250 was filed on april 5th 2017.Additional information (04/11/2017): a siemens technical applications specialist (tas) went to the customer site and checked the contamination avoidance settings on the instruments.The tas specialist found that the instrument that generated the discordant lipase result was not properly configured and was missing the avoidance settings for chol_c and trig, which could impact results and cause falsely elevated readings.The tas specialist configured this instrument with the correct settings and the customer has not encountered this issue since then.The avoidance settings on the other instrument were correct.The cause of the discordant, falsely elevated lipase result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• 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: 6461363
• MDR Text Key: 71836538
• Report Number: 2432235-2017-00250
• Device Sequence Number: 0
• Product Code: CHI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/11/2017

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 ANALYZER
• Device Catalogue Number: 10315183
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2017
• 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