MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 INTACT PTH

Model Number	IMMULITE 2000 INTACT PTH
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	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center.It was found that the customer would collect the sample in an edta tube, centrifuge sample and then transfer it to another edta tube.The customer performed a check with his own blood and drew 2 tubes of edta plasma.One tube was centrifuged and plasma transferred in a neutral tube (tube 1) and another tube was centrifuged and plasma transferred in an edta tube (tube 2).The result obtained from tube 1 was elevated and that from tube 2 was low.The customer stated that this explains the observed falsely low intact pth value obtained on an immulite 2000 xpi instrument and is in concordance with the immulite 2000 xpi instructions for use, which states "for edta plasma, keep specimens cold (2-8 degree celsius) throughout the collection and separation process.Separate the plasma from the cells, using a refrigerated centrifuge, if possible.Note that edta collection tubes must be filled to their capacity.Failure to completely fill the tube will result in excess concentration of edta which will interfere with the assay, causing a false depression of values." a siemens headquarters support center specialist reviewed the event data and concluded that siemens does not support transferring of the sample into another edta tube.Samples should be transferred into an aliquot tube.The device is performing within manufacturing specifications.No further evaluation of device is required.Mdr 2432235-2017-00543 was filed for the same event.
Event or Problem Description
Discordant, falsely low intact parathyroid hormone (intact pth) results were obtained on one patient sample on an immulite 2000 xpi instrument, while using kit lot 325.A new sample was obtained from the patient and was run on the same instrument using same kit lot, also resulting low.The redrawn sample (aliquot and primary tube) was sent to an alternate laboratory where it was tested on an alternate platform using a new intact pth assay, resulting higher.The primary tube for the redrawn sample was then tested using old intact pth assay on an alternate platform, also resulting higher.The discordant results obtained from the original sample draw were reported to the physician(s), who questioned them.It is unknown if the repeat results were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low intact pth results.

• Brand Name: IMMULITE 2000 INTACT PTH
• Common Device Name: IMMULITE 2000 INTACT PTH
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis; gwynedd, LL55 4EL; UK LL55 4EL
• MDR Report Key: 6913352
• Report Number: 2432235-2017-00542
• Device Sequence Number: 13725642
• Product Code: CEW
• UDI-Device Identifier: 00630414961910
• UDI-Public: 00630414961910
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

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 INTACT PTH
• Device Catalogue Number: L2KPP2
• Device Lot Number: 325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1