MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI TOTAL TRIIODOTHYRONINE

Model Number	IMMULITE 2000 XPI TOTAL TRIIODOTHYRONINE
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is investigating the issue.Mdr 2432235-2018-00073, mdr 2432235-2018-00075, mdr 2432235-2018-00076, mdr 2432235-2018-00077, mdr 2432235-2018-00078, mdr 2432235-2018-00079, mdr 2432235-2018-00080 were filed for the same event.
Event or Problem Description
The customer has informed siemens that they have obtained low results on patient samples for the total triiodothyronine (t3) assay on an immulite 2000 xpi system when using kit lot 347.It is unknown if any of the results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the low results obtained for total t3.
Additional Manufacturer Narrative
The initial mdr 2432235-2018-00074 was filed on february 21, 2018.Additional information (09/30/2019): a large reference range study was performed and reported a median and normal range values that are lower than those reported in the ifu.This reference range study has identified that there is a difference observed with different sample sets.The llanberis population demonstrated a 23% higher median in the patient samples results when compared to those reported through the sourced samples cohort from biomnis france.The total t3 ifu documentation states that for reference ranges "consider these limits as guidelines only.Each laboratory should establish its own reference ranges." the customers that have raised complaints have not indicated that they have set their own ranges based on the population.A review of the patient panel release data has demonstrated that over the period of (b)(6) 2017 through to (b)(6) 2019 there has not been a change in the assay performance when the same sample population is tested on subsequent kit lots.There are no statistically relevant differences observed.The qc data collated over a period of 3 years does not show that there has been a notable shift in assay performance.Good laboratory practice for each laboratory to establish their own normal range or verify a normal range provided by an outside source (ex.Textbook, manufacturer, peer-reviewed journal article, etc.).This is supported by laboratory guidance (ex.Clinical & laboratory standards institute) and various regulatory requirements (ex.The joint commission (united states)).In alignment with this, the assay ifu states that the normal range is considered as a guideline only, which should be verified by each customer for their population.Mdr's 2432235-2018-00073, mdr's 2432235-2018-00075, mdr's 2432235-2018-00076, mdr's 2432235-2018-00077, mdr's 2432235-2018-00078, mdr's 2432235-2018-00079, and mdr's 2432235-2018-00080 were filed for the same issue.

• Brand Name: IMMULITE 2000 XPI TOTAL TRIIODOTHYRONINE
• Common Device Name: IMMULITE 2000 XPI TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• MDR Report Key: 7286407
• Report Number: 2432235-2018-00074
• Device Sequence Number: 1993983
• Product Code: CDP
• UDI-Device Identifier: 00630414968599
• UDI-Public: 00630414968599
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K905214
• 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): 10/04/2019

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 XPI TOTAL TRIIODOTHYRONINE
• Device Catalogue Number: L2KT3
• Device Lot Number: 347
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1