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	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was dispatched to the customer site and discussed system performance with the customer.The cse inspected the system environment and determined that a bubble may have potentially caused the discordant result.The cse also found a contaminant in the water system.The counts per seconds for water were above 31000.The cse performed system decontamination and ran water test, which passed.The cse checked the voltages, alignments, and substrate temperatures.The cse ran quality controls, which were acceptable.There were no additional discordant results from the day the issue occurred.The cause of the discordant, falsely low tsh result on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant, falsely low thyroid stimulating hormone (tsh) result was obtained on one patient sample on an immulite 1000 instrument.The discordant result was reported to the physician(s).A new sample was obtained from the patient and run on the same instrument, resulting higher.One of the sample draw was sent to an alternate laboratory where it was tested on an alternate platform, resulting higher than the initial result and lower than the initial result of new sample draw.The customer repeated the original sample, which resulted higher.The rerun of the original sample draw was reported as a corrected result to the physician(s).One of the sample draw was again sent to the alternate laboratory where it was tested on the alternate platform, resulting higher this time.Both sample draws were then sent to a reference laboratory where they were tested on a different alternate platform, also resulting higher.There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low tsh result.
Additional Manufacturer Narrative
The initial mdr 2247117-2017-00141 was filed on 27-dec-2017.Additional information (15-jan-2018): patient's age, gender and diagnosis was unknown at the time the initial mdr was filed.This information has been received.

• 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: 7148068
• Report Number: 2247117-2017-00140
• Device Sequence Number: 11040194
• Product Code: JJE
• UDI-Device Identifier: 00630414947440
• UDI-Public: 00630414947440
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR