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

Model Number	IMMULITE 1000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report that a discordant, falsely high enhanced estradiol (ee2) test result was obtained from an immulite 1000 instrument.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the instrument.The cse found the substrate reservoir was giving false empty messages.The cse replaced the substrate reservoir assembly.The cause of the discordant falsely high enhanced estradiol (ee2) test result is the substrate reservoir assembly malfunction.The device is performing within manufacturing specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant, falsely high enhanced estradiol (ee2) test result was obtained from an immulite 1000 instrument.The initial result was reported to the physician(s).The same sample was repeated on the same instrument two days later giving a lower result.The repeat result was reported to the physician(s) and is considered correct.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely high enhanced estradiol (ee2) test result.

• Brand Name: IMMULITE 1000
• Common Device Name: IMMULITE 1000
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley road; flanders NJ 07836
• MDR Report Key: 8041462
• Report Number: 2247117-2018-00082
• Device Sequence Number: 11107562
• Product Code: LGD
• UDI-Device Identifier: 00630414947440
• UDI-Public: 00630414947440
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K022603
• 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
• Report Date (Section B): 11/06/2018

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 11/06/2018
• Patient Sequence Number: 1