MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 1000

Model Number	IMMULITE 1000
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	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the discordant, falsely elevated progesterone result is unknown.Siemens is investigating the issue.
Event or Problem Description
A discordant, falsely elevated progesterone result was obtained on an immulite 1000 instrument.The initial result was reported to the physician(s).It is unknown if the initial result was questioned by the physician(s).The same sample was repeated in an alternate laboratory, resulting lower.A corrected report with the lower progesterone result was issued to the physician(s).There are no known reports of patient intervention due to the falsely elevated progesterone result.There are no known reports of a delay in administering treatment or medical intervention to the patients due to the falsely elevated progesterone result.
Additional Manufacturer Narrative
The initial mdr 2247117-2019-00004 was filed on 11-jan-2019.Additional information (18-mar-2019): a siemens headquarter support center (hsc) specialist stated that the immulite 1000 instrument was decontaminated by a siemens customer service engineer (cse) and results of the water test decreased after the decontamination.The progesterone assay was re-adjusted, calibrator and quality control materials were tested and the assay performance was verified.The sample is no longer available for further investigation.The falsely elevated progesterone result may have been caused by issues with pre-analytical variables, sample handling or instrument.The cause of the discordant, falsely elevated progesterone result on the immulite 1000 instrument is unknown.The device is performing within specifications.No further evaluation of the device is required.The method, result and conclusion codes have been updated in evaluation codes.

• Brand Name: IMMULITE 1000
• Common Device Name: IMMULITE 1000
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd.; flanders NJ 07836
• MDR Report Key: 8241050
• Report Number: 2247117-2019-00004
• Device Sequence Number: 1558011
• Product Code: JJE
• UDI-Device Identifier: 00630414947440
• UDI-Public: 00630414947440
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K022603
• 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
• Report Date (Section B): 04/04/2019

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 1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1