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

Model Number IMMULITE 1000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

A siemens technical support center (tsc) specialist followed up with the customer and dispatched a siemens field service engineer (fse) to perform a full service check of the instrument.The customer cancelled service and stated that they performed additional system decontaminations and are no longer experiencing the issue.The tsc specialist reviewed the adjustment and quality control data provided by the customer and confirmed that the adjustments were valid and the quality control recoveries were within range.A siemens headquarter support center (hsc) specialist reviewed the information in the complaint and stated that a system contamination may have caused the discordant hcg result, which was resolved by a decontamination.The cause of the discordant, falsely low hcg result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.Mdr 2247117-2018-00005 was filed for the same event.

Event Description

A discordant, falsely low hcg result was obtained on an immulite 1000 instrument.The initial result was reported to physician(s).The same sample was repeated on an alternate platform at a reference laboratory and resulted higher.It is not known if the repeat result was reported to physician(s).There are no known reports of patient intervention due to the falsely low hcg result.There are no known reports of a delay in administering treatment or medical intervention to the patient due to the falsely low hcg result.

• Brand Name: IMMULITE 1000
• Type of Device: IMMULITE 1000
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd.; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley road; flanders NJ 07836
• Manufacturer Contact: devyani chaudhuri ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242637
• MDR Report Key: 7205574
• MDR Text Key: 98071531
• Report Number: 2247117-2018-00004
• Device Sequence Number: 0
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1