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

Model Number ADVIA 1800

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

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

Event Date 03/23/2018

Event Type  malfunction  

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 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
• Type of Device: CALCIUM_2 REAGENTS (CA_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; registration # 8020890; 55 diamond road; crumlin co. antrim, bt29 4QY ; UK 4QY
• Manufacturer Contact: marie sylvestre ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243172
• MDR Report Key: 7481085
• MDR Text Key: 107475268
• Report Number: 2432235-2018-00201
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00630414513096
• UDI-Public: 00630414513096
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083386
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 1800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1