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

Model Number ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

Device Problem Data Problem (3196)

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

Event Date 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens healthcare diagnostics inc.Field service engineer (fse) was dispatched to the customer site to determine the cause of the incorrect patient sample being smeared on a slide by the advia autoslide system after being sampled by the advia 2120i with dual aspirate autosampler instrument.The fse verified that the tube sensor was operating correctly and performed a preventative maintenance on the instrument.During the preventative maintenance, the fse found a corroded power cable and replaced it.The instrument was fully functional upon departure from the customer site.The cause of the incorrect smear produced on the advia 2120i wth dual aspirate autosampler instrument is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

The advia 2120i with dual aspirate autosampler instrument reported a tube too tall error but continued running.A patient sample with a low platelet count was run on the advia 2120i with dual aspirate autosampler instrument and a slide was produced on the advia autoslide system.The customer reviewed the slide and noted that the platelet count on the slide was inconsistent with what was reported by the advia 2120i with dual aspirate autosampler instrument.The low platelet count sample was rerun on the advia 2120i with dual aspirate autosampler instrument and on another advia hematology system in their laboratory and the platelet counts were similar.A manual blood smear was made and the correct platelet count was observed.The correct complete blood count (cbc) was reported to the physician.The laboratory investigated the issue and determined that the blood from a previously run patient sample was smeared on the incorrect slide.There are no known reports of patient intervention or adverse health consequences due to the incorrect patient sample being smeared on a slide by the advia autoslide system.

• Brand Name: ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; registration number: 8020888; chapel lane; swords, co. dublin ; EI
• Manufacturer Contact: elizabeth bernasconi ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242495
• MDR Report Key: 5542180
• MDR Text Key: 41694073
• Report Number: 2432235-2016-00161
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102644
• 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: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• 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: 03/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2014
• 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