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

Model Number ADVIA CENTAUR CP

Device Problem Device Issue (2379)

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

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The ccc specialist was informed that repeat testing has resulted in signal 1 error(s).The customer has ensured that quality controls (qc) results were in range during testing, and other assays run on the instrument are not affected.The customer has performed troubleshooting and informed that dark count test results are varying and inconsistent.Contamination has been ruled out by emptying the water and wash 1, rinsing and refilling the bulk bottles.The acid and base bottles were determined to be full and in their correct drawer positions.A customer service engineer (cse) was dispatched to the customer site.The cse performed inspections and determined the total hcg negative control is failing the pre-light ratio.A total service call was performed, and the luminometer required cleaning.The reagent probe alignment and fluid dispense were checked and operated within specifications.The customer has performed qc and ensured that results are in range.The instrument is operational and performing according to specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely elevated total human chorionic gonadotropin (total hcg) result was obtained on an advia centaur cp instrument.The customer stated the discordant result was obtained after performing repeat testing.The discordant result was not reported to the physician(s).The customer used the same instrument and patient sample to perform repeat testing.The repeated result of 2.7 miu/ml was obtained and reported.There are no reports of patient intervention or adverse health consequence due to the falsely elevated total hcg result.

• 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; gewerbestrasse 6; registration #: 3008494306; neuhausen am rheinfall 8212 ; SZ 8212
• Manufacturer Contact: rolando hualpa ; 511 benedict ave; tarrytown, NY 10591 ; 9145242963
• MDR Report Key: 7650466
• MDR Text Key: 112740446
• Report Number: 2432235-2018-00279
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: 00630414523286
• 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
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• 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: 06/05/2018
• 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