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

Model Number ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

Device Problem Data Problem (3196)

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

Event Date 09/30/2014

Event Type  malfunction  

Event Description

Discordant hemoglobin (hgb) and hematocrit (hct) results were obtained on three patient samples on the advia 2120i with dual aspirate autosampler system.The discordant results were flagged by the system and did not match the previous results for these three patients.The discordant results were reported to the physician(s).It is unknown if the physician(s) questioned the results.The three patients were redrawn and the hgb and hct values matched the patient history more closely.There are no known reports of patient intervention or adverse health consequences due to the discordant hgb and hct results.

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) investigated the cause of the event and determined that it was due to user error as the user released flagged hemoglobin (hgb) and hematocrit (hct) results obtained from the advia 2120i with dual aspirate autosampler without reviewing them first.The customer failed to follow operator guide instructions, which state "whenever such flags are triggered, the user should review the results and take the action recommended.".The customer informed siemens that they investigated the event regarding discrepant hgb and hct results on three patient samples and determined that the cause of the event was poor sample collection technique.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: 4148328
• MDR Text Key: 4915104
• Report Number: 2432235-2014-00586
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• 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: 09/30/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2009
• 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