MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000/IMMULITE 2000 XPI OM-MA

Model Number IMMULITE 2000/IMMULITE 2000 XPI OM-MA

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

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

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has confirmed that biotin interferes with the ca-125 (om-ma) assay on the immulite 2000/immulite 2000 xpi platform.At biotin concentrations of >5 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 u.S 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 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 om-ma (ca 125) assay.Two investigational samples were spiked with biotin at multiple concentrations, and run for investigational purposes on an immulite 2000/immulite 2000 xpi instrument.The results of the two samples spiked with 75 ng/ml and 250 ng/ml of biotin were falsely high with a bias of +41% 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.

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 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 OM-MA
• Type of Device: IMMULITE 2000/IMMULITE 2000 XPI OM-MA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; uk registration #: 3002806944; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 7118353
• MDR Text Key: 95617520
• Report Number: 2432235-2017-00645
• Device Sequence Number: 1
• Product Code: LTK
• UDI-Device Identifier: 00630414961088
• UDI-Public: 00630414961088
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K983391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IMMULITE 2000/IMMULITE 2000 XPI OM-MA
• Device Catalogue Number: L2KOP
• Device Lot Number: 290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2432235-12/19/2017-004-C
• Patient Sequence Number: 1