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

Model Number ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

Device Problems Appropriate Term/Code Not Available (3191); Device Handling Problem (3265)

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

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens healthcare diagnostics inc.Customer service engineer (cse) visited the customer site to determine the cause of the advia (b)(4) with dual aspirate autosampler instrument to misread a sample tube barcode.The cause of the event is under investigation.

Event Description

A patient sample tube identification number (id) was misread by the advia (b)(4) with dual aspirate autosampler instrument.The results from the incorrectly identified sample tube were reported to the physician, who questioned the results as the physician did not order a blood test for this patient.The laboratory investigated the issue and determined that the incorrect sample id was assigned to the sample tube.There are no known reports of patient intervention or adverse health consequences due to the incorrect sample tube id being assigned to the patient sample.

Manufacturer Narrative

Siemens healthcare diagnostics inc.Filed the initial mdr (2432235-2015-00589) on 12/26/2015.On 01/21/2016 - additional information: siemens healthcare diagnostics inc.(siemens) investigation found that the barcode symbology used by the customer was codabar without the check digit.The on-line advia 120/2120/2120i operator guide states "because our research indicates that the codabar symbology presents an unacceptable possibility of a misread barcode label when used with siemens hematology systems, we do not recommend its use.The codabar symbology should be used only if you cannot use any of the other symbologies listed above.If it is not possible to use one of the other symbologies, use codabar with a check digit and with barrier lines on the top and bottom of the barcode symbol.".Siemens has determined that the cause of the event is user error.The instrument is performing according to specifications.No further evaluation of this device is required.

• 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: 5323418
• MDR Text Key: 34303485
• Report Number: 2432235-2015-00589
• 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: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/04/2012
• 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