MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 CALCIUM ARSENAZO; CALCIUM_2 REAGENTS (CA_2)

Model Number	ADVIA 1800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was dispatched to the customer site.The cse observed that the incorrect calibration factor (cf) was being used on the instrument for the ca_2 assay.The calcium (ca) cf factor was being used instead of ca_2 factor.The cse changed the calibration factor on the instrument and noted that the quality control values dropped closer to the mean.The cause of the falsely high ca_2 values was due to the incorrect factor being used on the instrument.The device is performing within manufacturing specifications.No further evaluation of the device is required.
Event or Problem Description
Discordant, falsely elevated (18-20% higher) calcium arsenazo (ca_2) results were obtained on patient samples on an advia 1800 instrument.It is unknown which reagent lot was used.The customer has declined to provide any patient sample data to siemens.It is unknown if the samples were repeated and if the initial and/or repeat results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated calcium arsenazo results.

• Brand Name: ADVIA 1800 CALCIUM ARSENAZO
• Common Device Name: CALCIUM_2 REAGENTS (CA_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7481085
• Report Number: 2432235-2018-00201
• Device Sequence Number: 19240043
• Product Code: CJY
• UDI-Device Identifier: 00630414513096
• UDI-Public: 00630414513096
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K083386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ADVIA 1800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1