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

Model Number N/A

Device Problem False Reading From Device Non-Compliance (1228)

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

Event Date 03/02/2014

Event Type  malfunction  

Event Description

A falsely elevated advia centaur xp thcg dilution result was observed by the customer and the result was question by the clinician as not fitting the patient's clinical profile.The initial result was higher than the linear range of the assay and when the sample was auto diluted the result was elevated.The customer repeated the auto dilution and the result was lower than the initial auto dilution and what the clinician expected.A manual dilution was run and the result was similar to the repeat auto dilution result.The patient sample was tested on another advia centaur system for auto dilution and the result was similar to the repeat auto dilution and manual dilution results from the initial advia centaur xp system.The customer was unable to reproduce the discordant high elevated auto dilution result.There are no reports that treatment was altered or prescribed based on the discordant result.There are no reports of adverse health consequences based on the initially elevated advia centaur xp thcg dilution result.

Manufacturer Narrative

The cause for the falsely elevated advia centaur xp thcg initial auto dilution result when compared to the repeat dilution results is unknown.The customer's quality control results were within acceptable ranges at the time of the event, and there were no other discordant thcg results reported by the customer for the advia centaur xp thcg assay.The customer was unable to reproduce the discordant high elevated auto dilution result.No conclusion can be drawn.The instruction for use (ifu) under the procedural notes dilutions section states the following: "serum samples with hcg levels greater than 1000 miu/ml (iu/l) must be diluted and retested to obtain accurate results.Patient samples can be automatically diluted by the system or prepared manually.For automatic dilutions, ensure that advia centaur thcg diluent is loaded and set the system parameters as follows: < or = 1000 miu/ml (iu/l); dilution factor: 5, 10, 100, 200" the instruction for use (ifu) under the limitation section states the following: "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.".

• Brand Name: ADVIA CENTAUR XP TOTAL HCG (THCG)
• Type of Device: TOTAL HCG IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• 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: 3706535
• MDR Text Key: 18310476
• Report Number: 1219913-2014-00076
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K925277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 08/09/2014
• Device Model Number: N/A
• Device Catalogue Number: 03896216
• Device Lot Number: 029264
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: No
• 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