MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 ANTI-TG AB

Model Number IMMULITE 2000 ANTI-TG AB

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

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

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

The customer does not have any sample left for in-house testing.The cause of the discordant, falsely low anti-tg ab result on one patient sample is unknown.Siemens is investigating the issue.Mdr 2432235-2018-00093 was filed for the same issue.

Event Description

A discordant, falsely low result was obtained for autoantibodies to thyroglobulin (anti-tg ab) assay on one patient sample on an immulite 2000 xpi instrument, while using kit lot 675.The result from the immulite 2000 xpi instrument was reported to the physician(s), who questioned it.The sample was repeated on an alternate platform, resulting higher.It is unknown if the result from the alternate platform was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low anti-tg ab result.

Manufacturer Narrative

The initial mdr 2432235-2018-00092 was filed on 02-mar-2018.Additional information (05-apr-2018): a siemens headquarters support center (hsc) specialist reviewed the event data.The hsc specialist stated that without having a sample to perform in-house testing, knowing which alternate platform was used to perform repeat testing for sample in question or having other thyroid test results, the cause of the issue could not be determined.The potential cause of the issue was due to sample handling/sample preparation.Quality controls and adjustments were valid and with acceptable range.The device is performing within manufacturing specifications.No further evaluation of device is required.Result and conclusion codes have been updated in section h6.Mdr 2432235-2018-00093_s1 was filed for the same issue.

• Brand Name: IMMULITE 2000 ANTI-TG AB
• Type of Device: IMMULITE 2000 ANTI-TG AB
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis; gwynedd, LL55 4EL; UK LL55 4EL
• MDR Report Key: 7310279
• MDR Text Key: 101501941
• Report Number: 2432235-2018-00092
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 00630414962108
• UDI-Public: 00630414962108
• Combination Product (y/n): N
• PMA/PMN Number: K991094
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 ANTI-TG AB
• Device Lot Number: 675
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1