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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+
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SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+ Back to Search Results
Catalog Number 10379675
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2018
Event Type  malfunction  
Manufacturer Narrative
Siemens went onsite and reviewed maintenance and proper technique for testing.The customer states that no other issues have come up on any of the instruments and states the unit is operational.
 
Event Description
The customer reported they were getting both positive hcg and negative hcg on the same sample, on several patients, when run on the clinitek status+.There was no reported injury due to this event.
 
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Brand Name
CLINITEK STATUS+
Type of Device
CLINITEK STATUS+
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.
northern road
chilton industrial estate
sudbury, CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key7297850
MDR Text Key101158097
Report Number3002637618-2018-00023
Device Sequence Number1
Product Code JIL
UDI-Device Identifier00630414574639
UDI-Public00630414574639
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091216
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/26/2018
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 Number10379675
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/06/2018
Initial Date FDA Received02/26/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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