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

Model Number ADVIA 1800

Device Problem Device Issue (2379)

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

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

The customer called to the technical support center (tsc) to report a bad chloride (cl) electrode, which caused patient results to be affected.The customer changed the cl electrode on (b)(6) 2017 due to recommended maintenance.The customer successfully ran calibration and qc was within range.Then the customer noticed that some of the results were high and reran qc, which was out.The customer changed the cl electrode on (b)(6) 2017 again, which resolved the issue.The tsc sent a replacement cl electrode.The cause of the discordant cl results was a failed electrode.The instrument is performing according to the specifications.No further evaluation of this device is required.

Event Description

Discordant, falsely low chloride (cl) results were obtained on multiple samples on a advia 1800 instrument.Samples were repeated on same instrument, and recovered higher.The discordant results were reported to the physician(s).All samples were repeated on the same advia 1800 instrument.The repeat results were reported to the physician(s) for all samples.There are no reports of patient intervention or adverse health consequences due to the discordant cl 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: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6508577
• MDR Text Key: 73344765
• Report Number: 2432235-2017-00266
• Device Sequence Number: 0
• Product Code: CGZ
• 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: 04/20/2017

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: 03/29/2017
• Initial Date FDA Received: 04/20/2017
• 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