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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 BR-MA

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SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 BR-MA Back to Search Results
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.
 
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Brand NameIMMULITE 2000 BR-MA
Type of DeviceIMMULITE 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 Key5355093
MDR Text Key35494229
Report Number2432235-2016-00012
Device Sequence Number0
Product Code NIG
Reporter Country CodeBR
PMA/PMN Number
K013984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/15/2015
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received01/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIMMULITE 2000 BR-MA
Device Lot Number315
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2016
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

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