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 07/03/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and stated that the discordant result was obtained after they made changes to the software of a laboratory information system (lis).A siemens personnel was dispatched to the customer site and verified proper functioning of the advia 1800 instrument.It was determined that the lis sent serum sample as urine.The cause of the discordant, falsely elevated dbil_2 result on one patient sample is unknown.The instrument is performing within manufacturing specifications.No further evaluation of device is required.

Event Description

A discordant, falsely elevated direct bilirubin (dbil_2) result was obtained on one patient sample on an advia 1800 instrument.It is unknown if the initial result was reported to the physician(s).The sample was repeated on an alternate platform and the result was acceptable.The result obtained on the alternate platform was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated dbil_2 result.

Manufacturer Narrative

The initial mdr was filed on july 26, 2017.Event description has been updated with this information.Additionally, a siemens customer care center specialist stated that the issue occurred when the laboratory information system (lis) personnel updated the lis software.The customer's calibration was valid and the quality control was within range.The ccc specialist stated that the issue was due to the lis system, which sent the test orders to the advia 1800 instrument as urine samples and not serum samples.The lis personnel corrected the sample type on the lis software and the issue was resolved.

Event Description

The initial result was not reported to the physician(s).

• 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: karl aebig ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 6745123
• MDR Text Key: 81143656
• Report Number: 2432235-2017-00441
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• 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: 08/09/2017
• 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