MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY XPT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/26/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report the discordant calcium_2 (ca2_c) result, which occurred after water maintenance on the system.The customer provided quality control (qc) data, which indicated results were within range on the day of event.The ccc evaluated the data file, and stated the cause of the issue was the water source.A siemens customer service engineer (cse) was dispatched to the customer site.The cse ran couple of washes.The cse primed the instrument, and flushed water through the system to remove excess dissolved solid.The cse ran qc, and was in range.The cause of the discordant falsely low calcium_2 (ca2_c) result is due to source water.The instrument is performing according to the specifications.No further evaluation of this device is required.

Event Description

A discordant falsely low calcium_2 (ca2_c) result was obtained on one patient sample on an advia chemistry xpt instrument.The discordant result was not reported to the physician(s).The customer reran the original sample on the same instrument and on an alternate advia chemistry xpt instrument, resulting higher.The customer reported the result obtained on the alternate instrument to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant falsely low calcium_2 (ca2_c) result.

• Brand Name: ADVIA CHEMISTRY XPT
• Type of Device: ADVIA CHEMISTRY XPT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; gewerbestrabe 6; registration # : 3008494306; neuhausen am, rheinfall 8212 ; SZ 8212
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6642811
• MDR Text Key: 77626903
• Report Number: 2432235-2017-00362
• Device Sequence Number: 0
• Product Code: CJY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• 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