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

Model Number ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

Device Problem Aspiration Issue (2883)

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

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens healthcare diagnostics inc.Clinical service engineer (cse) was dispatched to the customer site to determine the cause of the sample tube being diluted by the advia 2120i with dual aspirate autosampler instrument.The cse changed the smearing tape on the advia autoslide system and replaced the sample tubing, liquid assay valve and pinch valve and performed maintenance on the sample syringe on the advia 2120i with dual aspirate autosampler instrument.The cse ran a dummy sample on the system to verify the instrument's functionality and no issues were found.The cause of the sample tube being diluted by the advia 2120i with dual aspirate autosampler instrument is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer discovered discordant, low differential results from a slide produced by the advia autoslide system compared to the complete blood count (cbc) results from the advia 2120i with dual aspirate autosampler instrument.The customer reran the same sample tube on the same advia 2120i with dual aspirate autosampler instrument and the cbc results were much lower than the initial results.Customer also noticed that the sample tube had more volume in the tube than when initially sampled.The initial, correct results produced by the advia 2120i with dual aspirate autosampler instrument were reported to the physician.

• 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: 5464220
• MDR Text Key: 39209981
• Report Number: 2432235-2016-00107
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• 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: 02/10/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2013
• 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