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

Model Number ADVIA 1800

Device Problem Mechanical Problem (1384)

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

Event Date 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and stated that the reagent probe 1 (rpp1) was crashing.A siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the instrument, the cse replaced the faulty rpp1 mechanism.The cse then verified the calibration and quality controls, which were acceptable.The cause of the discordant, falsely elevated (b)(6) results on multiple patient samples was due to an issue with the probe mechanism.The instrument is performing within manufacturing specifications.No further evaluation of device is required.

Event Description

Discordant, falsely elevated glucose hexokinase_3 (gluh_3) results were obtained on multiple patient samples on an advia 1800 instrument.The discordant results were reported to the physician(s).The samples were repeated on an alternate advia chemistry instrument, resulting lower.The corrected results obtained on the alternate advia chemistry instrument were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated gluh_3 results.

• Brand Name: ADVIA 1800
• Type of Device: ADVIA 1800
• 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, 96-85 58; JA 96-8558
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6464034
• MDR Text Key: 72264766
• Report Number: 2432235-2017-00239
• Device Sequence Number: 0
• Product Code: CFR
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• 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
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1