MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. 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 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating the issue.The cause of the discordant, falsely elevated ca 19-9 results on one patient sample is unknown.

Event Description

A discordant, falsely elevated cancer antigen (ca 19-9) result was obtained on one patient sample when diluted 1:3 on an immulite 2000 xpi instrument while using reagent lot 315.The discordant result was reported to the physician(s), who questioned it.The sample was tested in an alternate laboratory on an alternate platform, resulting lower.A new draw was obtained from the patient and was diluted with a dilution factor of 1:3 and tested on s/n: (b)(4), still resulting high.The original sample was sent to a supporting laboratory and was tested on an alternate immulite 2000 xpi instrument, also resulting high.It is unknown if the result from the alternate platform was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ca 19-9 results.

Manufacturer Narrative

The initial mdr 2432235-2016-00012 was filed on january 08, 2016.Additional information (02/26/2016): siemens requested the sample material from the customer for further investigation, but it was not provided.A siemens headquarters support center (hsc) specialist reviewed the patient data and indicated that they could not determine the cause of the event.The cause of the discordant, falsely elevated (b)(4) results on one patient sample is unknown.

• Brand Name: IMMULITE 2000 BR-MA
• Type of Device: IMMULITE 2000 BR-MA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; glyn rhonwy; llanberis, caernarfon; gwynedd, wales LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS (REG# 3002806944); glyn rhonwy; llanberis, caernarfon; gwynedd, wales LL55 4EL; UK LL55 4EL
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 5355093
• MDR Text Key: 35494229
• Report Number: 2432235-2016-00012
• 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: 12/15/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• 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 Lot Number: 315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 74 YR