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

Model Number ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Information (3190)

Event Date 04/05/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics' investigation has determined that the cause of reporting an incorrect platelet count that was obtained on an advia 2120i with single aspirate autosampler instrument is due to user error.The customer manually assigned the incorrect sample identification (sid) to a patient sample and released that result to the physician.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer incorrectly released a discordant platelet result that was obtained on the advia 2120i with single aspirate autosampler instrument.A patient sample with a normal platelet count was run on the advia 2120i with single aspirate autosampler instrument without a barcode.Later a second barcoded sample was run in the same rack position and resulted with a 15,000 platelet count (low).During the review and edit of results, the customer assigned the normal platelet sample with the sample identification (sid) number of the low platelet count sample and released the result to the physician.It is unknown if the physician questioned the results and if the patient was treated based on the platelet count.The customer did not provide the patient results for either patient sample.There are no known reports of patient intervention or adverse health consequences due to the discordant platelet result that was reported to the physician.

• Brand Name: ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120I 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: 5644250
• MDR Text Key: 44894413
• Report Number: 2432235-2016-00242
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10488923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2014
• 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