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

Model Number	IMMULITE 2000 ANTI-TG AB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the discordant, falsely low anti-tg ab results on patient samples is unknown.Siemens is investigating the issue.Mdr 2432235-2018-00033 was filed for the same issue.
Event or Problem Description
Discordant, falsely low autoantibodies to thyroglobulin (anti-tg ab) results were obtained on patient samples on an immulite 2000 xpi instrument, while using kit lot 673.The results from immulite 2000 xpi instrument were not reported to the physician(s).The samples were repeated on an advia centaur xpt instrument, resulting higher.The results from the advia centaur xpt instrument were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low anti-tg ab results.
Additional Manufacturer Narrative
Additional information (13-apr-2018): the customer provided patient samples for in-house testing.Siemens tsl ran 14 patient samples on an immulite 2000 instrument using kit lots 672 and 673 and on the advia centaur instrument using kit lot 298.Two samples could not be retested on the advia centaur instrument due to insufficient sample quantity.For the remaining samples, 9 of 12 samples were clinically concordant.A siemens headquarters support center specialist reviewed the event details and determined that the assays on the advia centaur and immulite 2000 xpi have different cut-offs, use different antigens and antibodies, and use different architectures.Most antibody assays have poor correlation to each other.The cause of the discordant anti-tg ab results on patient samples is unknown.No further evaluation of device is required.Mdr 2432235-2018-00033_s2 was filed for the same event.

• Brand Name: IMMULITE 2000 ANTI-TG AB
• Common Device Name: 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: 7371322
• Report Number: 2432235-2018-00127
• Device Sequence Number: 592333
• Product Code: JZO
• UDI-Device Identifier: 00630414962108
• UDI-Public: 00630414962108
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K991094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IMMULITE 2000 ANTI-TG AB
• Device Lot Number: 673
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1