MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT TOTAL HCG; HCG IMMUNOASSAY

Model Number N/A

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 10/01/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the false high total hcg result is unknown.A siemens field service engineer (fse) was sent to the customer site for system inspection on 10/04/2016.Siemens is awaiting further information from the customer site.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the ifu states in the limitations section: "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 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 false positive advia centaur xpt total hcg result was obtained for a patient sample.The patient sample was repeated on the second advia centaur xpt in duplicate and the results were negative.The negative result matched the health status of the patient.The negative results were reported.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 1219913-2016-00188 on october 26, 2016.On 12/01/2016 additional information: the siemens field service engineer (fse) report was provided.The fse found, during the verification of the vacuum circuit, a presence of a plug in the small y connector between the water trap and the waste reserve (fluidic schematics).The fse removed the jam/plug and cleaned the connector.The cause for the false high total hcg result appears to be due to the jam/plug in the connector.The instrument is performing within specifications.No further evaluation of the device is required.Advia centaur xpt instrument information: (b)(4), 510k #: k041133, product code: jje, catalog #: 10711433.

• Brand Name: ADVIA CENTAUR XPT TOTAL HCG
• Type of Device: HCG 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; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 6057229
• MDR Text Key: 58457297
• Report Number: 1219913-2016-00188
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• 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: 10308985
• Device Lot Number: 30835285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• 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
• Patient Age: 29 YR