MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP; IMMUNOASSAY ANALYZER

Model Number ADVIA CENTAUR CP

Device Problem Mechanical Problem (1384)

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

Event Date 09/24/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer's site.The cse performed annual preventative maintenance (pm) as pm was due.The cse replaced the peristaltic pump tubing.The cse also found buildup under the wash block.The cse corrected this issue.The cause of the discordant, falsely elevated enhanced estradiol results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely elevated enhanced estradiol (ee2), results were obtained four patient samples on an advia centaur cp instrument.The initial results were not reported out to the physician(s).For patient 1 the initial result was above range.The sample was diluted (1:5), resulting high.A redraw was taken the next day and tested, resulting above range.The redrawn sample was diluted 1:5, resulting high.The redrawn sample was then testing on an alternate advia centaur instrument, resulting lower.For patient 2, the initial result was elevated.The patient was redrawn, resulting lower.The redrawn sample was then repeated on the alternate advia centaur instrument, resulting lower.The customer also reported patient samples 10 and 11 also were elevated.The customer repeated the samples on their alternate advia centaur instrument, resulting lower.The results from the alternate advia centaur instrument were reported out to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant falsely elevated enhanced estradiol results.

Manufacturer Narrative

The initial mdr 2432235-2016-00642 was filed on october 20, 2016.Correction (11/15/2016): originally mdr 2432235-2016-00642 stated: "the results from the alternate advia centaur instrument were reported out to the physician(s)." the correction is: "the results from the alternate advia centaur instrument were not reported out to the physician(s).".

• Brand Name: ADVIA CENTAUR CP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; registration #: 3008494306; gewerbestrasse 6; neuhausen am rheinfall 8212 ; SZ 8212
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6045944
• MDR Text Key: 58022283
• Report Number: 2432235-2016-00642
• Device Sequence Number: 0
• Product Code: CHP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR CP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1