MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800; CLINICAL CHEMISTRY ANALYZER

Model Number ADVIA 1800

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

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

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

The cause of the discordant lipase result on one patient sample is unknown.Siemens is investigating the issue.

Event Description

Discordant lipase result was obtained on one patient sample on an advia 1800 instrument.The sample was repeated on the same instrument, resulting lower.It is unknown if the initial or repeat results were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant lipase result.

Manufacturer Narrative

The initial mdr 2432235-2017-00591 was filed on october 31, 2017.Additional information (07-nov-2017): a siemens headquarters support center specialist reviewed the event data.The true result is unknown and the event could not be confirmed.Potential causes could be inadequate washing of the probes, incorrect contamination avoidance settings, sample delivery or sample quality.At this time, there is no identified product non-conformance.The cause of the discordant lipase result on one patient sample is unknown.

Manufacturer Narrative

The initial mdr 2432235-2017-00591 was filed on 31-oct-2017.The first supplemental mdr 2432235-2017-00591_s1 was filed on 30-nov-2017.Additional information (20-jun-2018): the customer did not have additional issues for lipase on advia 1800 s/n: (b)(4).The instrument is performing within manufacturing specifications.No further evaluation of device is required.Conclusion code has been updated in section h6.

• Brand Name: ADVIA 1800
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 6991695
• MDR Text Key: 91211281
• Report Number: 2432235-2017-00591
• Device Sequence Number: 0
• Product Code: CHI
• Combination Product (y/n): N
• PMA/PMN Number: K990346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 1800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 10/31/2017
• Supplement Dates Manufacturer Received: 11/07/2017; 06/20/2018
• Supplement Dates FDA Received: 11/30/2017; 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1