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

Model Number 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 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating the event.

Event Description

A discordant, falsely low calcium (ca) result was obtained on a patient sample on an advia chemistry xpt instrument.The discordant result was reported to the physician(s), who questioned it.The sample was repeated on two alternate analyzers, resulting higher and matching.One of the repeated results was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low ca result.

Manufacturer Narrative

The initial mdr 2432235-2017-00253 was filed on (b)(6) 2017.Additional information ((b)(6) 2017): a siemens customer service engineer (cse) spoke with the customer who determined that no service intervention was needed for this issue.The customer replaced the lot of quality control (qc) with a new one on the day the event occurred.The cause of the falsely depressed calcium (ca) result is unknown.The instrument is performing within manufacturing specifications.No further evaluation of device is required.

• Brand Name: ADVIA CHEMISTRY XPT
• Type of Device: CLINICAL CHEMISTRY ANALYZER,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD REGISTRATION NUMBER: 3003637681; 3-1-2 musashino akishima; tokyo, 196-8 558; JA 196-8558
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6493806
• MDR Text Key: 72888139
• Report Number: 2432235-2017-00253
• Device Sequence Number: 0
• Product Code: CJY
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CHEMISTRY XPT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2015
• 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