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 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

The cause of the falsely elevated ca 15-3 results with kit lot 262 is unknown.Siemens is investigating the issue.

Event Description

The customer obtained falsely elevated ca 15-3 results on an immulite 2000 xpi instrument, while using kit lot 262.The initial result was reported to physician(s), who questioned the result.Repeat testing performed with the same sample and a new sample from the patient.The repeat results were also falsely elevated on the immulite 2000 xpi assay.The new sample from the patient was tested on an alternate platform at a different laboratory and the result was acceptable.It is unknown if the repeat results were reported to physician(s).There are no known reports of patient intervention due to the falsely elevated ca 15-3 result.There are no known reports of a delay in administering treatment or medical intervention to the patient due to the falsely elevated ca 15-3 result.

Manufacturer Narrative

The initial mdr 2432235-2017-00248 was filed on april 4th, 2017.Additional information (04/27/2017): a siemens headquarter support center (hsc) specialist reviewed the data provided by the customer and did not find any discrepancies with the assay adjustments and recoveries of quality control materials.The immulite 2000 br-ma (ca 15-3) instructions for use (ifu) states that 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 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 cause of the bias between the methods cannot be determined.There were no other reports of discordant results being obtained with lot 262.Based on the available information, immulite 2000 br-ma (ca 15-3) lot 262 is performing as intended.The cause of the falsely elevated ca 15-3 results with kit lot 262 on the immulite 2000 xpi instrument is unknown.No further evaluation of the device is required.

• Brand Name: IMMULITE 2000 BR-MA
• Type of Device: IMMULITE 2000 BR-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: devyani chaudhuri ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242637
• MDR Report Key: 6457722
• MDR Text Key: 71711755
• Report Number: 2432235-2017-00248
• 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,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: IMMULITE 2000 BR-MA
• Device Catalogue Number: L2KBR2
• Device Lot Number: 262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• 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
• Patient Sequence Number: 1