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

Model Number IMMULITE 2000

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

Patient Problems Miscarriage (1962); Patient Problem/Medical Problem (2688)

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluating the instrument and instrument data, the cse replaced the wash spinner and wash sump pump due to visible rust from the wash spinner.The cse also replaced the luminometer chain and detent gasket and aligned and tensioned the luminometer chain.A siemens regional support center (rsc) specialist evaluated the instrument data to determine if there were errors in the instrument level-sensing, which could cause inadequate sample volume to be aspirated for testing.The level sensing for patient id (b)(4) was inconclusive.The other level-sensing data was reviewed did not show any issues.A siemens technical applications specialist generated a precision study on hcg with the customer's quality controls.Precision for the assay and instrument resulted as expected.Quality controls on the day of event were within expected range.A siemens headquarters support center specialist evaluated the service report and instrument data and could not determine a cause for the discordant, false negative hcg result.The instrument data did not show a systemic issue.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, false negative human chorionic gonadotropin (hcg) result was obtained on one patient sample tested on an immulite 2000 instrument on (b)(6), 2015.The discordant result was reported to the physician(s) and the patient was instructed to stop taking medication.On (b)(6), 2015, the patient went to the emergency room (er) due to cramps.A new sample was drawn in the er and run on a different instrument, resulting with a positive hcg result.The patient miscarried and the fertility laboratory was notified.The original sample from the patient was repeated on the immulite 2000 instrument and resulted positive.A corrected report was issued to the physician(s).

Manufacturer Narrative

The initial mdr 2247117-2016-00006 was filed on january 25, 2016.Additional information (02/03/2016): the patient was an in vitro fertilization patient.Additional information (02/15/2016): siemens attempted to further investigate the event.The customer would not provide medication information due to their patient privacy practices.

• 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 rd; flanders NJ 07836
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 5389959
• MDR Text Key: 36822352
• Report Number: 2247117-2016-00006
• Device Sequence Number: 1
• Product Code: DGC
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• 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