MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE

Model Number IMMULITE

Device Problem Mechanical Problem (1384)

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

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.The customer complained of tip jam errors and short samples.The cse evaluated the instrument and found that the probe tip was loose.The cse tightened the probe tip and lubricated and cleaned the pipettor mechanism.The cse ran level-sensing and pipette testing routines.The cse ran quality controls and adjustments, which were acceptable.The cause of the discordant, falsely low ue3 results on patient samples is unknown.This instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely low unconjugated estriol (ue3) results were obtained on patient samples on an immulite instrument.The customer provided one example of the discordant ue3 result.The discordant results were reported to the physician(s), except for sample id (b)(6).The samples were repeated on the same instrument, resulting as expected.The repeat result for sample id (b)(6) was reported to the physician(s).It is unknown if corrected results were reported to the physician(s) for the other patients.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low ue3 results.

• Brand Name: IMMULITE
• Type of Device: IMMULITE
• 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: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 5709793
• MDR Text Key: 47216093
• Report Number: 2247117-2016-00032
• Device Sequence Number: 1
• Product Code: JJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905215
• 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: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1