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

Model Number ADVIA CHEMISTRY XPT

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and stated that a clotted patient sample resulted without a clot error on the advia chemistry xpt instrument.The customer reviewed the instrument data and determined that there were clot d errors associated with two other patient samples run ten minutes prior to the sample in question.These samples were initially run on an alternate advia chemistry instrument and then repeated on this instrument (s/n: (b)(4)), resulting the same.The customer also stated that other samples aspirated around the same time as the sample in question had resulted acceptable.A siemens headquarters support center (hsc) specialist reviewed the information and stated that the customer has an ongoing issue with all four of their advia chemistry instruments.The hsc specialist suspects water quality as the cause of the issue, however, there is an action plan to check the alignments and function of the clot detector.Siemens is investigating the issue.

Event Description

A discordant, falsely low total bilirubin_2 (tbil_2) result was obtained on one patient sample on an advia chemistry xpt instrument.The discordant result was not reported to the physician(s).The sample was repeated on an alternate advia chemistry xpt instrument, resulting higher.The result obtained on the alternate advia chemistry xpt instrument was 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 2432235-2017-00313 was filed on may 15, 2017.Additional information (04/18/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided by the customer and stated that there was no method or reagent issue.The investigation showed that clot d errors have been observed across all four advia chemistry xpt systems.The probe alignments were acceptable.Samples were reviewed and clots were visible in the specimens that received clot d errors.The hsc specialist also stated that when the system receives clot d errors and if there is an actual clot in the sample, it means that the system is performing as expected.Advia chemistry xpt s/n: (b)(4) was receiving clot c errors.A siemens customer service engineer was dispatched to the customer site on april 18, 2017 for an unrelated issue.After analyzing the instrument, the cse replaced the saline check valve and clot detection board and the clot c issue on the advia chemistry xpt s/n: (b)(4) system resolved.The hsc specialist concluded that the cause of the clot c error issue was due to the malfunction of a saline check valve and clot detection board.The device is performing within manufacturing specifications.No further evaluation of device is required.Corrected information (05/19/2017): the initial mdr indicate that the "date of event" and "date received by manufacturer" is (b)(6) 2017.The correct date is (b)(6) 2017.Updated with this information.

Manufacturer Narrative

The initial mdr was filed on 15-may-2017.The first supplemental mdr 2432235-2017-00313_s1 was filed on 19-may-2017.Corrected information (11-jul-2018): upon further review of this event by siemens, it was determined that the service details provided in the first supplemental mdr belongs to another advia chemistry system and not to advia chemistry xpt s/n: (b)(4).As indicated in the first supplemental mdr, a siemens headquarters support center specialist determined that when the system receives clot d errors and if there is an actual clot in the sample, it means that the system is performing as expected.Therefore, advia chemistry xpt s/n: (b)(4) was performing as intended.The cause of the discordant, falsely low total bilirubin_2 result on one patient sample is unknown.Pma/510k of the first supplemental mdr indicates the "date received by manufacturer" as 18-apr-2017.As the service detail of 18-apr-2017 is not related to advia chemistry xpt s/n: (b)(4), the correct date received by manufacturer for the first supplemental mdr is 18-may-2017 (date when investigation of the event was concluded by siemens).As per the corrected information provided in the first supplemental mdr, the "date of event" and "date received by manufacturer" were on (b)(6) 2017.Since the service details captured in first supplemental mdr are not related to advia chemistry xpt s/n: (b)(4), the correct "date of event" and "date received by manufacturer" for the initial mdr is on (b)(6) 2017.Date of event and device, method, result, and conclusion codes has been updated to reflect the correct information.Pma/510k cannot be updated as it has been used for this report.

• Brand Name: ADVIA CHEMISTRY XPT
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 6567620
• MDR Text Key: 75409819
• Report Number: 2432235-2017-00313
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• PMA/PMN Number: K990346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CHEMISTRY XPT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1