MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

Model Number IMMULITE 2000

Device Problem Low Test Results (2458)

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

Event Date 11/01/2014

Event Type  malfunction  

Event Description

A discordant, falsely low estradiol result was obtained on one patient sample on an immulite 2000 instrument.The discordant result was reported to the physician, who questioned it as it did not match a result previously obtained for the patient.The sample was repeated on the same instrument, resulting higher than the initial result.The same sample was repeated again on the same instrument, also resulting higher than the initial result.It is unknown if the corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low estradiol result.

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer's site.The cse evaluated the instrument and performed a total service call.The cse ran quality control (qc) samples which were within acceptable ranges.The cse also checked verifiers and the result for one level was high and patient samples showed imprecision.The cse replaced the sample and reagent dual resolution dilutor (drd) upper and lower seals.The cse ran precision study using qc samples for estradiol in replicates of 10 and all levels of verifiers in replicates of 3.All results were within acceptable ranges.The cause of discordant, falsely low estradiol result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: IMMULITE 2000
• Type of Device: IMMULITE 2000
• 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: 4282551
• MDR Text Key: 5008702
• Report Number: 2247117-2014-00086
• Device Sequence Number: 1
• Product Code: CHP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000
• Device Catalogue Number: 30002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2014
• 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