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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 Back to Search Results
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.

 
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Brand NameIMMULITE 2000
Type of DeviceIMMULITE 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 Key5389959
MDR Text Key36822352
Report Number2247117-2016-00006
Device Sequence Number1
Product Code DGC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK970227
Number of Events Reported1
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  
0 PatientS WERE Involved in the Event:
Date FDA Received01/25/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIMMULITE 2000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2016
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

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