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	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer care center (ccc) specialist provided adjustment data with kit lot 331 and quality control data with a previous lot for investigation.A siemens headquarter support center (hsc) specialist has requested quality control data with lot 331.The cause of the discordant, falsely depressed results with the immulite 2000 xpi intact pth assay is unknown.Siemens is investigating the issue.
Event or Problem Description
Discordant, falsely depressed results were obtained for patient samples with the immulite 2000 intact pth (parathyrin) assay.The initial discordant results were not reported to the physician(s).The samples were repeated with a different reagent lot of the same assay and resulted higher.The repeat results were in alignment with the clinical profile of the patients.It is unknown if the repeat results were reported to the physician(s).There are no known reports of any impact to patient treatment or intervention due to the discordant, falsely depressed intact pth results.There are no known reports of a delay in administering treatment or medical intervention to the patients due to the discordant, falsely depressed intact pth results.
Additional Manufacturer Narrative
Follow up mdr 2432235-2018-00341_s1 was filed on 19-oct-2018.Follow up mdr 2432235-2018-00341_s2 was filed on 14-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.
Additional Manufacturer Narrative
The initial mdr was filed on 17-sep-2018.Additional information (28-sep-2018): a siemens customer care center specialist (ccc) stated that the discordant results with immulite 2000 intact pth lot 331 were obtained as part of a correlation study and not during routine patient sample testing for diagnostic purposes.Additional information (01-oct-2018): the siemens technical support laboratory (tsl) evaluated immulite 2000 intact pth kit lots 329 (the next available kit lot after lot 328) and 331 with quality control materials from siemens and biorad.The quality control materials recovered within the established ranges for both the kit lots.Immulite 2000 intact pth kit lot 328 could not be evaluated as this kit has expired.A siemens headquarter support center (hsc) specialist reviewed in house data for kit lot 331.There was no bias outside of manufacturing specifications with patient samples and quality control materials for kit lot 331.The cause of the discordant results with immulite 2000 intact pth lot 331 is unknown.The assay is performing according to specifications.No further evaluation of the device is required.
Additional Manufacturer Narrative
The initial mdr was filed on 17-sep-2018.Supplemental mdr 2432235-2018-00341_s1 was filed on 19-oct-2018.Additional information (23-oct-2018): a siemens customer care center specialist (ccc) stated that the correlation study was carried out on immulite 2000 intact pth lots: 328 and 331 on the same day.The samples used were frozen and had undergone one freeze-thaw cycle.Additional information (09-nov-2018): a siemens customer care center specialist (ccc) made a clarification on the dates of the correlation study and stated that the results were generated on two days: 18-aug-2018 and 21-aug-2018.Correlation study results generated on 18-aug-2018: units: pg/ml lot: 331, lot: 328, 358, 300, 161, 100, 3,0, 19, 3,0, 8.06, 10.6, 3.1.Correlation study results generated on 21-aug-2018: units: pg/ml lot: 331, lot: 328, 352 , 436, 34.4, 41.6, 35, 44.8, 36.2, 43.6, 23, 33.4, 46.3, 67.5, 64.6, 84.2, 50.3 , 58.3, 29.8, 43.1, 25, 36.8.

• 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: 7880511
• Report Number: 2432235-2018-00341
• Device Sequence Number: 228666
• 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,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: Other
• Device Expiration Date: 02/28/2019
• Device Model Number: IMMULITE 2000 INTACT PTH
• Device Catalogue Number: L2KPP2
• Device Lot Number: 331
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 09/28/2018; 10/23/2018; 11/08/2019
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 10/19/2018; 11/14/2018; 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1