MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI INTACT IPTH; IMMULITE 2000 XPI INTACT IPTH, PRODUCT CODE: CEW

Model Number	IMMULITE 2000 XPI
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The siemens customer application specialist (cas), provided the assay adjustment data for reagent kit lots 329 and 333 and quality control data to headquarter support center for the investigation.The cause of the discordant, falsely depressed results with the immulite 2000 xpi intact pth kit lot 333 assay is unknown.Siemens is investigating the issue.Mdr# 2432235-2018-00356 was filed for the same issue.
Event or Problem Description
Discordant, falsely depressed results were obtained on patient samples for the intact parathyroid (ipth) assay on kit lot 333 compared to kit lot 329 on an immulite 2000 xpi instrument.The results obtained on kit lot 333 were lower than the results obtained on kit lot 329 for the same samples.The falsely depressed results on kit lot 333 were reported to the physician(s).The customer ran samples on (b)(6), but did not indicate to siemens which samples were run on which day.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed ipth results.
Additional Manufacturer Narrative
The initial mdr 2432235-2018-00355 was filed on (b)(6) 2018.Correction (b)(6) 2018): a correction was made to section, to reflect the correct kit lot number as 333.
Additional Manufacturer Narrative
The initial mdr 2432235-2018-00355 was filed on 04-sept-2018.Follow up mdr 2432235-2018-00355_s1 was filed on 01-nov-2018.Additional information (08-nov-2019): siemen's investigation has determined that the immulite 2000 / immulite 2000 xpi intact parathyroid hormone (ipth) assay kit lots 329, 331, 333, and 334 were performing within manufacturers specifications during the shelf life of the product.Statistical analysis between the kits lots demonstrated a statistically relevant agreement with an overlap in the confidence intervals.There has been no statistical evidence indicating a kit lot bias and data shows agreement between the kit lots.In addition an in depth statistical analysis was carried out using 75 different kit lots and 80 patient samples.The data generated fell within the historic assay performance, is performing within the expected precision, and within manufacturer specifications.The ipth assay is performing as intended.Mdr's # 2432235-2018-00356_s2 was also filed for the same issue.

• Brand Name: IMMULITE 2000 XPI INTACT IPTH
• Common Device Name: IMMULITE 2000 XPI INTACT IPTH, PRODUCT CODE: CEW
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis; gwynedd, LL55 4EL; UK LL55 4EL
• MDR Report Key: 7943994
• Report Number: 2432235-2018-00355
• Device Sequence Number: 931110
• Product Code: CEW
• UDI-Device Identifier: 00630414961910
• UDI-Public: 00630414961910
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2019

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
• Device Lot Number: 333
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 11/01/2018; 11/08/2019
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 11/01/2018; 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1