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

Model Number ADVIA 1800

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

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

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens field service engineer (fse) was dispatched to the customer's site.The fse performed decontamination on the instrument.Siemens is investigating the event.

Event Description

A discordant, falsely elevated enzymatic creatinine result was obtained on a patient sample on an advia 1800 instrument.It is unknown if the initial result was reported out to the physician(s).The customer repeated the same sample on the same advia 1800 instrument, twice, resulting lower.The customer did not issue a corrected report to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated enzymatic creatinine result.

Manufacturer Narrative

The initial mdr 2432235-2017-000299 was filed on april 30, 2017.Additional information (04/06/2017): a siemens customer service engineer (cse) was dispatched to the customer site.The cse decontaminated the cuvette wash and conditioner lines, adjusted the distribution volume of reaction tray washer (wud), adjusted reagent probes 1 and 2 and decontaminated sample-dilution probe, sample probe, and reagent probes 1 and 2 lines.The cse returned to the customer site and inspected the wud and discovered the yellow line was clotted.The cse washed the station with bleach, adjusted its height, and adjusted nozzle 2 height.The cse replaced the silicon connector.The cse washed the lines on the dilution washer (dwud), adjusted its height and replaced the silicon connectors.The cse adjusted the reagent probe heights and replaced and adjusted the dilution probe as it was bent.The cse also replaced the saline tank tubing.The cse checked the mixer and adjusted its height.The cse checked the instrument software and amended the decontamination settings.The cause of the discordant, falsely elevated enzymatic creatinine result is unknown.The sample id of the patient in question was (b)(6).The initial result was not reported to the physician(s).The instrument is performing according to specifications.No further evaluation of the device is required.

• 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: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6533216
• MDR Text Key: 74157109
• Report Number: 2432235-2017-00299
• Device Sequence Number: 0
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2017
• 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: 04/06/2017
• 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