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

Model Number ADVIA 2120 WITH SINGLE ASPIRATE AUTOSAMPLER

Device Problem Data Problem (3196)

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

Event Date 02/29/2016

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 barcode mis-read on two patient samples on the advia 2120 with single aspirate autosampler instrument.The cse found that there was an unfixed barcode cover on the autosampler and he replaced it with a new one.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

Two patient sample identification numbers (sids) were misread on the advia 2120 with single aspirate autosampler instrument.(b)(6).The customer discovered the issue when sids (b)(6) were left in an incomplete status on the instrument.No incorrect patient results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the advia 2120 with single aspirate autosampler instrument mis-reading the two patient sample identification numbers.

• Brand Name: ADVIA 2120 WITH SINGLE ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120 WITH SINGLE 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: 5541529
• MDR Text Key: 41667693
• Report Number: 2432235-2016-00160
• 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: 03/08/2016

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 2120 WITH SINGLE ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10316162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2005
• 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