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

Model Number ADVIA 1800

Device Problems False Device Output (1226); Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2014

Event Type  malfunction  

Event Description

Discordant, falsely low calcium results were obtained on patient samples on an advia 1800 instrument.The discordant results for two of the patient samples were reported to the physician(s), but were corrected immediately.The samples were repeated on the same instrument and an alternate instrument and all resulted higher on both.There are no reports of patient intervention or adverse health consequences due to the discordant calcium results.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse cleaned and flushed the wash up down and dilution wash up down, replaced a filter and seals on the sample probe and dilution probe pumps, and cleaned and calibrated all probes and mixers.The cse ran a diagnostics test, which passed.The cause of the discordant calcium results is unknown.The instrument is performing according to specifications.No further evaluation of this 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- 8558; JA 196-8558
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 4131980
• MDR Text Key: 16451659
• Report Number: 2432235-2014-00576
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 09/09/2014
• 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