MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE/IMMULITE 1000 OM-MA

Model Number	IMMULITE/IMMULITE 1000 OM-MA
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 ca-125 (om-ma) assay on the immulite/immulite 1000 platform.At biotin concentrations of >2 ng/ml a positive bias that exceeds 10% has been observed on immulite/immulite 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/ immulite 1000 instrument when using the om-ma (ca 125) assay.Two investigational samples were spiked with biotin at multiple concentrations, and run for investigational purposes on an immulite/ immulite 1000 instrument.The results of the two samples spiked with 75 ng/ml of biotin were falsely high with a bias of +45% and +38% respectively compared to results of the two samples without biotin.There were no patient samples impacted as this was for investigational purposes only.
Additional Manufacturer Narrative
The initial mdr 2432235-2017-00644 was filed on december 14, 2017.Corrected information (12/18/2017): based on input from the (b)(4) recall coordinator on 12/18/2017 this recall was re-submitted to the (b)(4) office (oradevices1recalls@fda.Hhs.Gov).The crr reporting number indicated 9 is incorrect and was changed to 2432235-12/19/2017-004-c.In addition it was indicated that an "urgent medical device recall (umdr) was sent to us customers.This is incorrect as an "urgent medical device correction (umdc)" was sent to us customers on december 13, 2017.

• Brand Name: IMMULITE/IMMULITE 1000 OM-MA
• Common Device Name: IMMULITE/IMMULITE 1000 OM-MA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• MDR Report Key: 7118352
• Report Number: 2432235-2017-00644
• Device Sequence Number: 16368862
• Product Code: LTK
• UDI-Device Identifier: 00630414961088
• UDI-Public: 00630414961088
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K981297
• 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 an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: IMMULITE/IMMULITE 1000 OM-MA
• Device Catalogue Number: L2KOP
• Device Lot Number: 290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• 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