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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. CLINITEK STATUS; CT STATUS
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SIEMENS HEALTHCARE DIAGNOSTICS, INC. CLINITEK STATUS; CT STATUS Back to Search Results
Catalog Number 10332185
Device Problem Invalid Sensing (2293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2013
Event Type  Other  
Manufacturer Narrative
The customer has been re-trained for proper sampling technique.The customer has also been offered upgraded software which will flag this error.
 
Event Description
Customer reported that a multistix 10sg dipstick read erroneously as a multistix pro 10lb dipstick on the instrument.There was no report of injury for this event.
 
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Brand Name
CLINITEK STATUS
Type of Device
CT STATUS
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict ave
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.
northern rd.
chilton industrial estate
sudbury, suffolk CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
steve andberg
2 edgewater dr.
norwood, MA 02062
7812693655
MDR Report Key3581674
MDR Text Key19400605
Report Number1217157-2013-00244
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 Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10332185
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/12/2013
Initial Date FDA Received01/06/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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