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

Model Number N/A

Device Problem Low Test Results (2458)

Patient Problem No Information (3190)

Event Date 01/15/2014

Event Type  malfunction  

Event Description

Customer observed a falsely low advia centaur xp thcg result compared to the results of a follow-up sample drawn two weeks after the initial sample.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 low advia centaur xp thcg result.

Manufacturer Narrative

The cause of the discordant advia centaur total hcg is unknown.A siemens service engineer (fse) was sent to the customer site for system inspection and checked the reagent and sample probe alignment, acid and base dispense and the wash station and luminometer performance.Instrument was operational.The fse ran quality control material in 20 replicates and all results were within range and showed good precision.The instrument is performing within specification.The initial sample was discarded and is not available for further evaluation and the initial results could not be confirmed.The customer could not confirm if the original tube was labelled correctly.No further investigation is required.The limitations section of the instructions for use states: "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: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 3653894
• MDR Text Key: 4201380
• Report Number: 1219913-2014-00052
• 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 Facility
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2014
• Device Model Number: N/A
• Device Catalogue Number: 00643953
• Device Lot Number: 029260
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2014
• 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