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

Model Number ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER

Device Problem Mechanical Problem (1384)

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

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse replaced the reagent pump assembly and red blood cell shuttle tubing.The cse then verified functionality, calibration and gains, hemoglobin precision and quality controls, all of which were acceptable.The cse ran patient samples, resulting without error or discrepancies.The cause of the discordant hemoglobin and white blood cell results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant hemoglobin and white blood cell results were obtained on twenty patient samples on the advia 2120 with dual aspirate autosampler instrument.The samples were repeated on the same instrument, and the results did not match the initial results.No results have been reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant hemoglobin and white blood cell results.

• Brand Name: ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown 10591 ; 9145243105
• MDR Report Key: 5333139
• MDR Text Key: 34758166
• Report Number: 2432235-2015-00591
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971418
• 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: 12/04/2015

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 2120 WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10313419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: No
• 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