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

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 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

The quality control (qc) was acceptable at the time of the run.The customer ran a precision run with another patient sample and the results were acceptable.A siemens field service engineer (fse) was sent to the customer site.The fse performed a total service call (checked fluidics, probe alignment and luminometer).No issues were identified.The cause for the discordant total hcg results is unknown.Possible preanalytical factor.The instrument is performing within specification.No further evaluation of the device is required.The ifu states in the limitations section: "all in vitro assays can generate erroneous results, both clinically false positive results (test results suggesting a condition that is absent) and clinically false negative results (test results failing to identify a condition that is present).If an aberrant or abnormal result, as defined by the laboratory protocol, occurs, laboratory personnel should first make certain that the system is performing and is operated and maintained in accordance with the product labeling.The user should then follow the laboratory protocol for advising the clinician of a result that appears to have deviated from the norms established by the laboratory.Test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal non-pregnant 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 false positive advia centaur cp total hcg result was obtained for a patient sample.The customer's procedure is to run all hcg samples in duplicate.The patient sample was run in duplicate and the results were negative.The patient sample was repeated again and the result was negative.The customer performed a qualitative test on the sample and the result was negative.The negative result was reported.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant total hcg result.

• Brand Name: ADVIA CENTAUR CP 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: 6092439
• MDR Text Key: 59753368
• Report Number: 1219913-2016-00211
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925277
• 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: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2017
• Device Model Number: N/A
• Device Catalogue Number: 00643953
• Device Lot Number: 029285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2016
• 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