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

Model Number N/A

Device Problems Incorrect Or Inadequate Test Results (2456); High Readings (2459)

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

Event Date 02/14/2014

Event Type  malfunction  

Event Description

The customer observed two falsely elevated advia centaur cp total hcg (thcg) diluted patient sample results that did not match the clinical picture or the neat results for those samples.There are no reports that treatment was altered or prescribed based on the results.There are no reports of adverse health consequences based on the falsely elevated advia centaur thcg results.

Manufacturer Narrative

A siemens field service engineer went on site and performed a full inspection of the instrument.A review of the instrument error logs indicate no problems or errors which could impact assay testing.Check of probe calibrations, aspiration wash station and reagent dispense confirm the instrument is performing properly.All other tests performed that day were repeated with no discrepancies.The cause of the discordant results is unknown.Quality control results are within acceptable ranges.To troubleshoot the issue, the customer performed a 1:200 on-board dilution of a sample and compared it to a manual 1:200 dilution of the sample.The results were 37443 miu/ml and 34260 miu/ml respectively indicating that the system is performing within specification.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 CP 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: 3683746
• MDR Text Key: 21968341
• Report Number: 1219913-2014-00063
• 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: 02/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2014
• Device Model Number: N/A
• Device Catalogue Number: 00643953
• Device Lot Number: 029266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2014
• 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