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	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer engineer (cse) was dispatched to the customer site.The cse performed a total service visit, verified pipetting, wash and substrate operation.The cse also performed preventive maintenance and did not find any problems contributing to the low result for turbo ipth.Quality controls (qc) and precision results were also within specifications.The cause of the falsely low turbo ipth result is unknown.The instrument is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant, falsely low result was obtained during surgery for turbo intact parathyroid (ipth) on one patient sample on an immulite 1000 instrument.The physician(s) questioned the result expecting it to be higher.The sample was repeated twice on the same instrument and resulted higher.The higher results were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low turbo ipth result.
Additional Manufacturer Narrative
The initial mdr was filed on 24-may-2018.Additional information (16-july-2018): based on the information provided by the customer siemens headquarters support center (hsc) has determined that a potential cause for the discordant result could have been due to the water lines not being primed sufficiently, as the repeated result was the correct and expected value after the system was primed.No further evaluation of the device is required.

• 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: 7542089
• Report Number: 2247117-2018-00049
• Device Sequence Number: 2435492
• Product Code: JJE
• UDI-Device Identifier: 00630414947440
• UDI-Public: 00630414947440
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/30/2018

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: 05/09/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1