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	06/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer care center (ccc) specialist stated that some of the samples with low intact pth results were repeated on the immulite 2000 xpi and the immulite 2000 xpi results were considered to be correct.It is not known if the repeat testing was performed with intact pth kit lot 323 or an alternate lot.The customer is currently using immulite 2000 intact pth kit lot 324 and is not seeing this issue.The cause of the low intact pth results with kit lot 323 is unknown.Siemens is investigating the issue.
Event or Problem Description
Low intact pth results were obtained with kit lot 323 on an immulite 2000 xpi instrument when compared to an alternate platform.It is not known if the initial results for each of the samples were reported to physician(s) or if repeat testing was performed on each sample to confirm the results.There are no known reports of patient intervention due to the low intact pth results.There are no known reports of a delay in administering treatment or medical intervention to patients due to the low intact pth results.
Additional Manufacturer Narrative
The initial mdr 2432235-2017-00402 was filed on june 29th, 2017.Additional information (07/21/2017): a siemens headquarter support center (hsc) specialist stated that the actual number values or the analytical values between two different methods could be different.Intact pth assays from different manufacturers may produce different results due to different standardizations for each assay, the position of the antibody epitopes in each assay and differences in the way in which each assay detects heterophilic antibodies which may be present in patient samples.Moreover, immulite 2000 intact pth kit lot 323 expired on may 31st 2017.Additional information (07/24/2017): the customer is performing routine testing with another kit lot.The cause of the low intact pth results with kit lot 323 is unknown.The assay is performing according to specifications.The result code and conclusion code have been updated with this information.No further evaluation of the device is required.

• 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: 6678599
• Report Number: 2432235-2017-00402
• Device Sequence Number: 18850036
• Product Code: CEW
• UDI-Device Identifier: 00630414961910
• UDI-Public: 00630414961910
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K013566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2017

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: Other
• Device Expiration Date: 05/31/2017
• Device Model Number: IMMULITE 2000 INTACT PTH
• Device Catalogue Number: L2KPP2
• Device Lot Number: 323
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1