MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

Model Number ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

Device Problem Insufficient Information (3190)

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

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was dispatched to the customer site.The fse verified the instrument and ran a few sample tubes to try and reproduce the problem.There were air bubbles in the sample line.The fse took apart the sampling module, cleaned it, put it back on the system and verified the needle alignment, 3 way valve and the sample line.The fse noticed that there was a rupture at the collar which may have been done during maintenance performed by the customer.The rupture at the collar was introducing air in the lines, which resulted in bad sample aspiration.The fse fixed the sample line, primed the assembly and ran a series of tests, which passed.The customer ran controls and validated the results based on their defined criteria.System was operational upon leaving the lab.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

Discordant, complete blood count (cbc) results were generated on four patient samples on the advia 2120i with dual aspirate autosampler instrument.The discordant results were reported to the physician.The results of those four patient samples were not provided by the customer.The system did generate alarms for some of the patient samples.The same patient samples were repeated on a second advia 2120i with dual aspirate autosampler and those results were correct and reported to the physician.There were no reports of patient intervention or adverse health consequences due to the discordant cbc results.

Manufacturer Narrative

Siemens healthcare diagnostics inc.Filed the initial mdr (2432235-2017-00021) on january 3, 2017.January 9, 2017 additional information: the customer has provided patient data for two of the four discordant patient results.Siemens investigation has determined that the customer did not follow operator guide instructions which state: through the use of complex flagging algorithms, laboratory personnel are alerted to suspected abnormal sample or system conditions.Sample/system flags display on the run screen and the review/edit tab.Whenever such flags are triggered, the user should review the results and take the action recommended.The customer released flagged results without following their laboratory's procedure on how to handle such results.

• Brand Name: ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; chapel lane; registration# 8020888; swords, co. dublin, ; EI
• Manufacturer Contact: loriann russo ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242287
• MDR Report Key: 6220041
• MDR Text Key: 63805634
• Report Number: 2432235-2017-00021
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10285573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2011
• 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