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

Model Number	IMMULITE 2000 XPI - IPT
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center.Siemens headquarters support center (hsc) reviewed the information provided by the customer.Hsc reviewed the instrument spyfiles, found no level sense issues for either the sample or the reagent.Quality control (qc) and calibration were reported to be valid.Hsc found that the error log does not give indication of any instrument issues that would cause discordant ipth results.Hsc reviewed internal data for ipth lot 353 and found that it met all release specifications.Hsc could rule out pre-analytical factors or a sample specific issue.The cause for the discordant falsely elevated ipth samples results is unknown.The instrument is performing within specification.No further evaluation of the device is required.
Event or Problem Description
Discordant, falsely elevated intact parathyroid hormone (ipt) results were obtained using immulite 2000 xpi.The initial results were reported to the physician(s) and questioned.The samples were repeated 2 times using the same immulite 2000 xpi.The first repeat results were considered correct and were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ipt results.

• Brand Name: IMMULITE 2000 XPI - IPT
• Common Device Name: IMMULITE 2000 XPI - IPT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; UK LL55 4EL
• MDR Report Key: 9764059
• Report Number: 2432235-2020-00218
• Device Sequence Number: 3267604
• Product Code: CEW
• UDI-Device Identifier: 00630414964515
• UDI-Public: 00630414964515
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K013566
• 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): 02/27/2020

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: 12/31/2017
• Device Model Number: IMMULITE 2000 XPI - IPT
• Device Catalogue Number: 10381399
• Device Lot Number: 0353
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1