MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 BR-MA

Model Number IMMULITE 2000 BR-MA

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

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

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens headquarters support center (hsc) specialist reviewed the data provided by the customer.The hsc specialist informed the customer that the immulite 2000 br-ma (cancer antigen 15-3) instructions for use (ifu) states the assay is for the quantitative measurement of br-ma in human serum, as an aid in the detection of recurrence in previously treated stage ii and stage iii breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment.It is not a screening assay.The expected values section of the ifu indicates there are small percentages of samples that will recover greater than 38 u/ml (normal females 5-6%, pregnant females 10%, and females without malignant disease 26%).As noted in the ifu, ca 15-3 antigen levels in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods and reagent specificity.Results reported by the laboratory to the physician must include the identity of the assay used to measure ca 15-3 antigen levels.Values obtained with different assays cannot be used interchangeably.Before changing assays, the laboratory must confirm baseline values for patients being serially monitored.The immulite br-ma assay is a sandwich immunoassay that uses murine monoclonal antibodies to capture and detect ca 15-3 in serum.It is unknown which antibodies are used on the alternate platform.The cause of the discordant, falsely elevated br-ma results on one patient sample is unknown.The br-ma assay is performing as intended.

Event Description

A discordant, falsely elevated br-ma (cancer antigen 15-3) result was obtained on one patient sample on an immulite 2000 xpi instrument while using kit lot 257.It is unknown if the discordant result was reported to the physician(s).The patient underwent image testing and there was no suspicion of any type of cancer.A new sample was obtained from the customer and was tested on the same instrument using kit lot 260 and the result was still elevated.The customer sent the sample to another laboratory where the sample was tested on an alternate platform.The result on the alternate platform was lower.The result obtained on the alternate platform was reported to the physician(s).There were no reports of adverse health consequences due to the discordant, falsely elevated br-ma results.

• Brand Name: IMMULITE 2000 BR-MA
• Type of Device: IMMULITE 2000 BR-MA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; registration #: 3002806944; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; 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: 6029671
• MDR Text Key: 57564353
• Report Number: 2432235-2016-00623
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K013984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 BR-MA
• Device Catalogue Number: L2KBR
• Device Lot Number: 237/240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2016
• 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
• Patient Sequence Number: 1