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

Model Number ADVIA CHEMISTRY XPT

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

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

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and stated that the error result obtained on the day of the issue could not be located.Quality controls before and after running affected patient sample was within acceptable range.Due to the low volume available the sample was poured off into a small sample container cup which was inserted to the original tube for analysis on the system.All four results for tbil_2 were analyzed in the similar manner.The customer inspected the sample visually after the first result with k flag, which was found to be free of fibrin, hemolysis and bubbles.The customer did not run serum indices test on the system.The sample was front loaded on the sample turntable of the system.The customer was advised to check the sample tubes and cups for sufficient sample volume and reagent container for foam or bubbles.Quality controls were acceptable for other assays.The customer is monitoring the performance of tbil_2.There are no reports of additional discordant results.The cause of the discordant, falsely low tbil_2 result on one patient sample is unknown.The instrument is performing within manufacturing specifications.No further evaluation of device is required.

Event Description

A discordant, falsely low total bilirubin_2 (tbil_2) result was obtained on one patient sample upon automatic repeat testing on an advia chemistry xpt instrument.The sample was initially run on the same instrument, resulting as an error with a k flag, indicating that the maximum absorbance limit was exceeded.The discordant result was reported to the physician(s), who questioned it.The sample was repeated twice on the same instrument, resulting higher both times.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low tbil_2 result.

Manufacturer Narrative

The initial mdr 2432235-2017-00544 was filed on october 4, 2017.Additional information (10/06/2017): a siemens headquarters support center (hsc) specialist reviewed the data provided and stated that there was no reagent or method issue.The hsc specialist also stated that the sample being poured off into a sample cup is consistent with poor aspiration due to bubbles or foam in the sample or possible alignment of the probe to the sample cup.The issue was isolated to one sample.The advia chemistry xpt total bilirubin_2 (tbil_2) instructions for use indicate ensuring samples are free of bubbles, fibrin prior to analysis.The customer is being more vigilant of the sample integrity prior to analysis and has not had another occurrence.The cause of the discordant, falsely low tbil_2 result on one patient sample is unknown.

• Brand Name: ADVIA CHEMISTRY XPT
• 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: karl aebig ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 6914484
• MDR Text Key: 88233203
• Report Number: 2432235-2017-00544
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/30/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CHEMISTRY XPT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/04/2017
• Supplement Dates Manufacturer Received: 10/06/2017
• Supplement Dates FDA Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/03/2015
• 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