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 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer's quality controls were within the acceptable ranges on both days.A siemens customer service engineer (cse) was dispatched to the customer site.The cse performed visual protocol, verified and adjusted reagent and sample probe calibrations, because the rings were off.The cse adjusted the sample probe reference voltage.Then the operator ran qc, resulting out of specification.The operator recalibrated the reagent and sample probes.The operator reran qc, resulting satisfactory.At the customer's request, the cse returned on site and performed preventive maintenance service.The cse ran patient samples, of which, the first few results were erroneous and the instrument flagged volume checks.The cse noticed splatter around the wash cup and replaced the defective probe assembly reagent with tubing and syringe.The cse reran the samples and precision, resulting satisfactory.The cse ran quality control (qc), resulting within range.The cause of the discordant, falsely elevated ee2 result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely elevated enhanced estradiol (ee2) result was obtained on a patient sample on an advia centaur cp instrument.The discordant result was reported to the physician(s) who questioned it.The sample was repeated the next day on the same instrument, resulting lower.The patient was redrawn and tested, and the result matched the original sample repeat.The original sample repeat result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ee2 result.

Manufacturer Narrative

The initial mdr was filed on 26-sep-2017.Corrected information (26-dec-2017): the initial mdr has incorrect manufacturing site address.

• Brand Name: ADVIA CENTAUR CP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; registration #: 3008494306; neuwiesenstrasse 4; beringen 8222, ; SZ
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6895158
• MDR Text Key: 89462311
• Report Number: 2432235-2017-00524
• 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: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2017
• 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