MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ADVIA CHEMISTRY XPT ENZYMATIC CREATININE_2

Model Number ADVIA CHEMISTRY XPT

Device Problem Low Test Results (2458)

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

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

The cause of the discordant ecre_2 patient result on the advia chemistry xpt instrument is unknown.Siemens is investigating the issue.

Event Description

A discordant, falsely depressed result was obtained on a patient sample for the enzymatic creatinine_2 (ecre_2) assay on an advia chemistry xpt instrument.The initial discordant result was not reported to the physician(s).The same patient sample was repeated on the same instrument, resulting higher.The corrected result was issued to the physician(s), as it met the clinical status of the patient.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed ecre_2 result.

Manufacturer Narrative

The initial mdr was filed on 06-nov-2018.Additional information (09-nov-2018): a siemens customer care center (ccc) specialist provided a correction to the date of event.The event date had been incorrectly stated as on (b)(6) 2018, instead of on (b)(6) 2018.Date of event and relevant tests/laboratory data have been updated with this correction.Additional information (09-nov-2018): the siemens ccc specialist stated that the repeat enzymatic creatinine_2 (ecrea_2) result was in alignment with the patient's clinical history.The discordant result may have been caused due to a sample specific issue.Additional information (21-nov-2018): a siemens headquarter support center (hsc) specialist reviewed the information in the complaint.The hsc specialist was unable to assess assay kinetics as the reaction curve data was not available.The hsc specialist recommended monitoring the performance of dilution cuvette washer (dwud), reaction cuvette washer (wud) and mixing of reagent 1 (r1) and reagent 2 (r2).The hsc specialist asked to ensure that the reaction (rrv) segments are not loose and that the reaction pipetting probes 1 and 2 (rpp1 and rpp2) are adjusted to the middle of the cuvettes.The hsc specialist also asked to ensure that the reagent probes are cleaned properly.The cause of the discordant, falsely depressed enzymatic creatinine_2 (ecrea_2) result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.Method, result and conclusion codes have been updated.

• Brand Name: ADVIA CHEMISTRY XPT ENZYMATIC CREATININE_2
• Type of Device: ADVIA CHEMISTRY XPT ENZYMATIC CREATININE_2
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 8041916
• MDR Text Key: 128256484
• Report Number: 2432235-2018-00409
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 00630414526690
• UDI-Public: 00630414526690
• Combination Product (y/n): N
• PMA/PMN Number: K070727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CHEMISTRY XPT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1