MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000/IMMULITE 2000 XPI CEA

Model Number	IMMULITE 2000/IMMULITE 2000 XPI CEA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics has confirmed that biotin interferes with the cea assay on the immulite 2000/immulite 2000 xpi platform.At biotin concentrations of >2 ng/ml a positive bias that exceeds 10% has been observed on immulite 2000/immulite 2000 xpi platforms.This issue affects previously manufactured, in-date, and future lots.The immulite platform instructions for use (ifu's) currently do not have biotin listed as a potential interferent.An urgent field safety notice (ufsn) imc 18-02.A.Ous was sent out to ous customers and an urgent medical device recall (umdr) imc18-02.A.Us was sent to us customers on december 13, 2017.The ufsn and umdr informs the customers of biotin interference on all affected immulite assays.Siemens will update all ifu's with the appropriate biotin information.
Event or Problem Description
Siemens technical operations internal investigation has identified that discordant falsely high results were obtained on two investigational samples on an immulite 2000/ immulite 2000 xpi instrument when using the carcinoembryonic (cea) assay.The investigational sample was spiked with biotin at multiple concentrations, and run for investigational purposes on an immulite 2000/immulite 2000 xpi instrument.The result of the sample spiked with 1200 ng/ml of biotin were falsely high with a bias of +31% compared to the result of the sample without biotin.There were no patient samples impacted as this was for investigational purposes only.
Additional Manufacturer Narrative
The initial mdr was filed on december 14, 2017.Corrected information (12/18/2017): based on input from the (b)(6) recall coordinator on 12/18/2017 this recall was re-submitted to the (b)(6) office (b)(4).The crr reporting number indicated in section h9 is incorrect and was changed to (b)(4).An "urgent medical device correction (umdc)" was sent to us customers on december 13, 2017.

• Brand Name: IMMULITE 2000/IMMULITE 2000 XPI CEA
• Common Device Name: IMMULITE 2000/IMMULITE 2000 XPI CEA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• MDR Report Key: 7118364
• Report Number: 2432235-2017-00646
• Device Sequence Number: 13684752
• Product Code: DHX
• UDI-Device Identifier: 00630414961088
• UDI-Public: 00630414961088
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K980855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,study
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: IMMULITE 2000/IMMULITE 2000 XPI CEA
• Device Catalogue Number: L2KCE
• Device Lot Number: 313
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2432235-12/19/2017-004-C
• Patient Sequence Number: 1