MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400

Model Number ADVIA 2400

Device Problem Mechanical Problem (1384)

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

Event Date 05/27/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The customer stated that the instrument produced dilution tray overflow errors on the day discordant result was obtained.The cse reviewed the instrument data and determined there were multiple patient results with negative values.The cse checked the reaction tray washer and dilution washer for overflows and completed wash 2.The cause of the discordant, falsely low aat results 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 low alpha-1-antitrypsin (aat) result was obtained on one patient sample on an advia 2400 instrument.The initial result was reported to the physician(s), who questioned it.The sample was repeated on an alternate advia chemistry instrument, resulting higher and matching the clinical picture of the patient.A new sample tube was obtained from the patient and was run on the alternate advia chemistry instrument, also resulting higher.The corrected result obtained from the new sample tube on the alternate advia chemistry instrument was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low aat result.

Manufacturer Narrative

The initial mdr 2432235-2017-00380 was filed on june 22, 2017.Additional information (07/07/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided and concluded that there was no method or reagent issue.The hsc specialist stated that overflow of the dilution tray wash station would have diluted the sample and impacted result.The cause of the discordant, falsely low alpha-1-antitrypsin result on one patient sample is unknown.

• Brand Name: ADVIA 2400
• Type of Device: ADVIA 2400
• 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: 6661572
• MDR Text Key: 78259450
• Report Number: 2432235-2017-00380
• Device Sequence Number: 0
• Product Code: DEM
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/02/2017

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 2400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: 07/07/2017
• Supplement Dates FDA Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2008
• 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
• Patient Age: 54 YR