MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400; CLINICAL CHEMISTRY ANALYZER

Model Number ADVIA 2400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Ccc evaluated the customer's rf assay settings which were correct and dilution was correctly configured.A siemens headquarter support center (hsc) specialist evaluated the event data.Hsc determined that if a result is returned with "//////" flag this cannot be interpreted as high or low.The flag is a calculation error.When the flag is obtained along with a "j" flag, this indicates the value is above the absorbance of the highest calibrator standard and thus the value is greater than the analytical measurement range (amr).In addition, the only dilution ratio validated by siemens is 1:10.If the sample, after being automatically diluted by the system, is still off curve and greater than the amr, the assay can be manually diluted using saline.The customer has been trained on interpretations of flagged results.The cause of the customer reporting falsely low rf results to the physician(s) was a user error.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Two patient samples were tested on the advia 2400 instrument for rheumatoid factor (rf).The results were flagged by the instrument, indicating the results were above the analytical measurement range.The customer did not interpret the flags correctly and instead of repeating the samples, reported falsely low results for the two patients.The samples were repeated on the same instrument, resulting higher.It is unknown if the corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the falsely low rf results reported to the physician(s).

Manufacturer Narrative

The initial mdr 2432235-2016-00082 was filed on february 16, 2016.Additional information (02/16/2016): in addition to the user error described initially, a siemens headquarter support center (hsc) specialist evaluated the event data.The issue was an incorrect laboratory information system (lis) configuration at the customer site.The lis sent new order requests to the system so the original order was removed.The system reacted as receiving a new order and ran the test as original instead of rerun with dilution.The system did flag appropriately with flags, indicating that the result was above the upper limit of linearity for the assay.The lis configuration was corrected and the account reports that the issue is resolved.

• Brand Name: ADVIA 2400
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; registration number:3003637681; 3-1-2 musashino akishima; tokyo, 196-8 558; JA 196-8558
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5439175
• MDR Text Key: 38287282
• Report Number: 2432235-2016-00082
• Device Sequence Number: 0
• Product Code: DHR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K990346
• 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: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 2400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• 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