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 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics inc.Is investigating the cause of the discordant high %reticulocyte result on the advia 2120i with dual aspirate autosampler instrument.

Event Description

A discordant high %reticulocyte result was obtained on an patient sample on an advia 2120i with dual aspirate autosampler (daa).The initial result was reported to the physician and questioned.The same sample was run on another advia 2120i with daa and a lower result was obtained.Corrected report was issued to the physician.There were no reports of patient intervention or adverse health consequences due to the discordant, high %reticulocyte result.

Manufacturer Narrative

Siemens healthcare diagnostics inc.Filed the initial mdr 2432235-2017-00140 on february 23, 2017.March 17, 2017 additional information: siemens healthcare diagnostics' investigation has determined that the discordant result displayed a rtc-fs flag on the advia 2120i with dual aspirate autosampler (daa).This was due to a problem with the gaussian fit of the reticulocyte absorption histogram.The optipoint printout provided by the customer also showed the pulse width (modulator) was too high and should be 21.0 +/- 0.3.The other advia 2120i with dual aspirate autosampler (daa) did not report a flag and that result was accepted and a corrected report was issued to the physician.Siemens investigation determined that the cause of the discordant high %reticulocyte result was due to failure of the customer to follow the operator guide instructions.The operator's guide states for the operator to perform a reticulocyte count using a manual smear when an rtc-fs flag is generated.Whenever such flags are triggered, the user should review the results and take the action recommended.The customer released a flagged %reticulocyte result without following their laboratory's procedure on how to handle such results.The instrument is performing within specifications.No further evaluation of this device is required.Method code, result code and conclusion code were updated to reflect the results of the investigation.

• 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: 6352682
• MDR Text Key: 68219777
• Report Number: 2432235-2017-00140
• 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,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• 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: 10404381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2012
• 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