MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP TOTAL HCG (THCG)

Model Number N/A

Device Problems Incorrect Or Inadequate Test Results (2456); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the falsely depressed total hcg result is unknown.The technical application specialist (tas) performed a precision run and the overall precision with the quality control (qc) and the patient samples yielded acceptable results.Siemens healthcare diagnostics is investigating.The ifu states in the limitations section: "test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal nonpregnant subjects.A physician's diagnosis involves evaluation of the test result in conjunction with, and in the context of, the patient's medical history, physical examination, and other test results, sometimes in consultation with other medical experts.".

Event Description

A falsely depressed advia centaur xp total hcg patient result was obtained for a patient sample.The patient sample was repeated twice and the results were higher.The patient sample was processed on two advia centaur xp systems.The results were not reported to the physician.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant total hcg result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00071 on april 21, 2016.On 04/25/2016 additional information: the patient sample was not available for in-house testing and investigation.The precision was checked by the technical application specialist (tas) at the customer site and no issues were identified.The precision was reviewed for in-house data and no imprecision was noted.The cause appears to be related to preanalytical handling including possibly fibrin, incomplete clotting and/ or incorrect spinning.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP TOTAL HCG (THCG)
• Type of Device: TOTAL HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 5596645
• MDR Text Key: 43287718
• Report Number: 1219913-2016-00071
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K925277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/12/2016

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: Health Professional
• Device Expiration Date: 07/09/2016
• Device Model Number: N/A
• Device Catalogue Number: 00643953
• Device Lot Number: 279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2015
• 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