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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS; CT STATUS
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SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS; CT STATUS Back to Search Results
Catalog Number 10332185
Device Problems False Device Output (1226); Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2014
Event Type  malfunction  
Event Description
Customer received false negative results for leukocytes whearas results in reference lab was positive.There was no report of injury due to this event.
 
Manufacturer Narrative
Customer took instrument out of service after receiving test results.No additional information has been made available by customer.
 
Manufacturer Narrative
Customer changed their cleaning procedure from using regular water to distilled water when cleaning the test table and using proper cleaning techniques is what resolved the issue.Instrument is working as intended.Customer reiterated that there have been no issues with results since this change.
 
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Brand Name
CLINITEK STATUS
Type of Device
CT STATUS
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict ave
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS
manufacturing, ltd.
northern road
sudbury, suffolk CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key3894778
MDR Text Key4675024
Report Number1217157-2014-00089
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number10332185
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/15/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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