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

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 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer reported that after a laboratory move, their calcium results shifted high.Ccc reviewed quality control (qc) data, which indicated results were within range.A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument, the cse stated the issue seems to affect both advia and dimension instruments after changing the water connections from ceiling drop to automation after the laboratory move.The cse turned off the calcium method while water was flushing thru the system.The cse ran the system all day to clear contaminates.The cse reactivated calcium, calibrated, and ran qc, all of which resulted as expected.The customer reran patient samples and corrected results were obtained.The cause of the discordant calcium results is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.

Event Description

Discordant, falsely high calcium (ca) results were obtained on multiple patient samples on an advia 1800 instrument.The discordant results were reported to the physician(s).Samples were repeated on dimension vista instrument, and recovered lower.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant ca 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; 3-1-2 musashino akishima; registration#: 3003637681; tokyo, 196-8 558; JA 196-8558
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6527114
• MDR Text Key: 74039857
• Report Number: 2432235-2017-00285
• Device Sequence Number: 0
• Product Code: CJY
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• 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: 04/04/2017
• Was Device Evaluated by Manufacturer?: No
• 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