MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CKMB ASSAY; CKMB IMMUNOASSAY

Model Number N/A

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

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

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was sent to the customer's site for system inspection.There were no instrument issues found that may have contributed to the non reproduced elevated ckmb result.The customer had run master curve material (mcm) for troubleshooting, and the results for all levels were within acceptable ranges indicating that the assay is performing as expected.The cse made new calibrators, ckmb recalibration performed, and quality control (qc) results were acceptable.The cse ran the previously used calibrators made by the customer as test samples, and the results were observed to be higher.It is not known what the status of the qc was for that day as the customer did not provide qc data.The cause for the discordant, falsely elevated ckmb result may be attributed to compromised calibrator material.No conclusion can be drawn.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A falsely elevated advia centaur xp ckmb patient result was observed by the customer.The patient sample was retested on an alternate advia centaur system.All of the repeat ckmb results were lower.The initially discordant ckmb result was not reported to the physician.There is no known report of patient treatment being prescribed or altered.There is no report of adverse health consequences due to the discordant advia centaur xp ckmb patient result.

• Brand Name: ADVIA CENTAUR XP CKMB ASSAY
• Type of Device: CKMB IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole, MA 02032
• Manufacturer Contact: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 6324255
• MDR Text Key: 67498677
• Report Number: 1219913-2017-00022
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/10/2017

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
• Device Operator: Medical Technologist
• Device Expiration Date: 06/03/2017
• Device Model Number: N/A
• Device Catalogue Number: 10309982
• Device Lot Number: 29986205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1