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

Model Number ADVIA 1800

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/19/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and stated that a discordant lipase result was obtained on a patient sample, when the sample was run from the rack handler.The same sample was processed in the sample carousel and the result obtained matched the clinical picture of the patient.The cause of the discordant, falsely elevated lipase result on one patient sample is unknown.Siemens is investigating the issue.

Event Description

A discordant, falsely elevated lipase result was obtained on one patient sample on an advia 1800 instrument.The initial result was not reported to the physician(s).The sample was repeated on the same instrument, resulting lower and matching the clinical picture of the patient.The repeat result was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated lipase result.

Manufacturer Narrative

The initial mdr 2432235-2017-00365 was filed on june 15, 2017.Additional information (05/31/2017): a siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the instrument, the cse cleaned the wash probe, sample dilution probe (dpp) and sample pipetting probe.The cse replaced the sample probe and aligned the dpp arm and wash station.A siemens technical application specialist (tas) performed precision testing.The tas and the cse determined that the sample tube with which discordant result was obtained was without gel.The cause of the discordant, falsely elevated lipase result on one patient sample is unknown.The instrument is performing within manufacturing specifications.No further evaluation of device is required.

• Brand Name: ADVIA 1800
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD. (REGISTRATION # 3003637681); 3-1-2 musashino akishima; tokyo, 196-8 558; JA 196-8558
• Manufacturer Contact: karl aebig ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 6642725
• MDR Text Key: 77625723
• Report Number: 2432235-2017-00365
• Device Sequence Number: 0
• Product Code: CHI
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 07/27/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/15/2017
• Supplement Dates Manufacturer Received: 05/31/2017
• Supplement Dates FDA Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2013
• 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