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

Model Number ADVIA 1800

Device Problems False Device Output (1226); High Test Results (2457)

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

Event Date 05/27/2014

Event Type  malfunction  

Event Description

A discordant, falsely elevated sodium (na) result was obtained on one of four draws obtained from the same patient on an advia 1800 instrument.The discordant result was reported to the physician(s), who questioned it.The sample was repeated on two alternate instruments, resulting lower.It is unknown if the corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated na result.

Manufacturer Narrative

The cause of the discordant, falsely elevated na result is unknown.Siemens is investigating this issue.

Manufacturer Narrative

The initial mdr 2432235-2014-00381 was filed on june 20, 2014.Correction (05/28/2014): the discordant result was not reported to the physician(s), as it did not match the patient's clinical history.Additional information (05/28/2014): the customer contacted the siemens technical solutions center (tsc).The customer performed the daily maintenance procedure and ran calibrations, which results within range.The cause of the discordant, falsely elevated na result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The discordant result was not reported to the physician(s), as it did not match the patient's clinical history.

• 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 number:3003637681; 3-1-2 musashino akishima; tokyo, 196- 8558; JA 196-8558
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 3887194
• MDR Text Key: 4539768
• Report Number: 2432235-2014-00381
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K990346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 1800
• Device Catalogue Number: 073-A021-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2014
• 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