MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI - TSH

Model Number	IMMULITE 2000 XPI - TSH
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center.Siemens headquarters support center (hsc) reviewed the data provided by the customer.The customer was not able to supply siemens with a list of medications that the patient was taking, and hsc could not determine which medications could possibly be interfering with tsh.Hsc determine the probable cause of the discordant result is assay interference by the medications that the patients was taking.The issue was resolved at the customers site.The instrument is performing within specification.No further evaluation of the device is required.
Event or Problem Description
One discordant, falsely depressed thyroid stimulating hormone (tsh) result was obtained using immulite 2000 xpi.The initial result was reported to the physician(s) and was questioned.The sample was repeated using the same immulite 2000 xpi.The repeat result reported to the physician(s).The customer could not confirm the correct result.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tsh results.

• Brand Name: IMMULITE 2000 XPI - TSH
• Common Device Name: IMMULITE 2000 XPI - TSH
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; EI LL55 4EL
• MDR Report Key: 8895261
• Report Number: 2432235-2019-00292
• Device Sequence Number: 16534465
• Product Code: JLW
• UDI-Device Identifier: 00630414962160
• UDI-Public: 00630414962160
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K933212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2019

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 Expiration Date: 07/31/2019
• Device Model Number: IMMULITE 2000 XPI - TSH
• Device Catalogue Number: L2KRT3M
• Device Lot Number: 669
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR