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

Model Number ADVIA CENTAUR CP

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/18/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The customer stated that they ran quality controls, which were acceptable.The customer also ran calibration before repeating the new sample.A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse performed a total service call and preventive maintenance.The cse ran quality controls, coefficient of variation check and calibration.The cse determined that level 1 quality control was out of range.The cse installed a new calibrator and ran quality controls, which were acceptable.The cse also performed patient correlation and the results were acceptable.The cause of the discordant, falsely low ee2 result on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely low enhanced estradiol (ee2) result was obtained on one patient sample on an advia centaur cp instrument.The discordant result was reported to the physician(s).The physician administered gonal f 100 to the patient due to the discordant result.A new sample was obtained from the patient the following day and tested on the same instrument, resulting higher.The customer reported the result to the physician(s) and the physician questioned this result as the result was much lower a day before.The customer repeated both of the samples on the same instrument, both of which resulted higher.The corrected result was reported to the physician(s) for the original sample.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low ee2 result.

Manufacturer Narrative

The initial mdr 2432235-2016-00311 was filed on june 13, 2016.Additional information (05/24/2016): while a siemens customer service engineer (cse) specialist was at the customer site, the cse determined that the grey peripump tubing was collapsed.As a part of preventive maintenance the cse replaced the grey peripump tubing and cleaned the luminometer as it had base residual and build up inside.A siemens headquarters support center (hsc) specialist reviewed the service report and indicated that the damaged grey peripump segments would cause poor aspiration of unbound material from the cuvette and a higher than expected relative light unit result which would result in a lower dose result.The cause of the discordant, falsely low ee2 result on one patient sample is unknown.

• 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; neuwiesenstrasse 4; beringen, 8222 ; SZ 8222
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 5720932
• MDR Text Key: 47293821
• Report Number: 2432235-2016-00311
• 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: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• 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: 05/24/2016
• 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: Reuse
• Patient Sequence Number: 1