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

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 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist and stated that this was an isolated issue impacting only one patient sample.A siemens headquarters support center (hsc) specialist reviewed the reaction curves for the discordant results and determined that the discordant results showed an abnormal reaction for the assay for samples from that patient.The hsc specialist determined that the instrument and assay were performing as expected.The cause of the discordant, falsely low crea_2 results on one patient is unknown.This instrument is performing according to specifications.No further evaluation is required.

Event Description

Discordant, falsely low creatinine_2 (crea_2) results were obtained on one patient upon repeat testing on an advia 1800 instrument.The sample was initially tested using a different sample on the same instrument and on an alternate advia 1800 instrument and the results were numerically (b)(6).The customer obtained two new samples from the patient and tested them on the same instrument, resulting falsely low both times.The customer then obtained another new sample from the patient and tested it on the same instrument and the result was numerically (b)(6).The discordant results were not reported to the physician(s).The customer sent a third redraw sample to another hospital, which was tested on an alternate platform and the result was higher.The repeat result from the alternate platform was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low crea_2 results.

• 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: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 5736725
• MDR Text Key: 47793485
• Report Number: 2432235-2016-00315
• Device Sequence Number: 0
• Product Code: CGX
• Reporter Country Code: MY
• 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
• Report Date: 06/20/2016

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: 05/26/2016
• Initial Date FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 2 MO