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

Model Number	IMMULITE 2000
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) visited the customer site.Both immulite 2000 instruments were evaluated and cse performed a total service visit on both systems.The cse inspected and tested the probe level sense, sample and reagent motor locations, tube lifter positions, shaker bar height, and dilution well mix speed.Both systems are performing within manufacturing specifications.The cause of the discordant falsely low results on the immulite 2000 intact pth assay when using kit lot 332 and 333 is unknown.Siemens is investigating the issue.Mdr's # 2432235-2018-00427 was also filed for the same issue.
Event or Problem Description
A discordant falsely low result (below reference range of the assay ) was obtained on a patient sample for intact parathyroid (ipth) assay on an immulite 2000 (instrument 1) instrument when using ipth kit lot 332.The initial result obtained on instrument 1 was reported to the physician(s) and questioned.The sample was then repeated on another immulite 2000 instrument (instrument 2) in the same laboratory twice using ipth kit lot 333 and the result was still low (below reference range of the assay).The result obtained on instrument 2 was not reported to the physician(s).The sample was then tested on an alternate non-siemens platform and the result was within the reference range of that assay.The customer is unclear what the true expected result is but has indicated that the physician(s) expected a result higher than the result on instrument 1.There were no previous ipth results on this patient sample.The customer has indicated that quality control samples recovered within specifications on the day the discordant result(s) were obtained on both the immulite 2000 instruments, and that the sample was frozen in between testing on the instrument(s).There are no reports of patient intervention or adverse health consequences due to the discordant falsely low ipth result.
Additional Manufacturer Narrative
The initial mdr 2432235-2018-00428 was filed on 15-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 # 2432235-2018-00427_s1 was also filed for the same issue.

• Brand Name: IMMULITE 2000 INTACT IPTH
• Common Device Name: IMMULITE 2000 INTACT IPTH
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis; gwynedd, LL55 4EL; UK LL55 4EL
• MDR Report Key: 8074739
• Report Number: 2432235-2018-00428
• Device Sequence Number: 19236483
• Product Code: CEW
• UDI-Device Identifier: 00630414961910
• UDI-Public: 00630414961910
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K013566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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
• Device Lot Number: 333
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1