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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
Model Number 10379675
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/04/2019
Event Type  malfunction  
Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results.The customer stated they are not sure if maintenance is performed.Siemens has made several attempts to the customer to provide more information to properly assess this complaint.There has been no confirmation that they will be providing the requested information.The cause of the event is unknown.
 
Event Description
The customer reported false negative urine leukocyte results on two patients on the clinitek status+ when compared to results from a non-siemens lab analyzer.There was no report of injury due to this event.
 
Manufacturer Narrative
Siemens has demonstrated due diligence by reaching out to customer several times for additional information.The customer has not responded.No investigation can be performed without the requested information.The root cause of this event is unknown.
 
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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
MDR Report Key9451869
MDR Text Key174175112
Report Number3002637618-2019-00130
Device Sequence Number1
Product Code JIL
UDI-Device Identifier00630414574639
UDI-Public00630414574639
Combination Product (y/n)N
PMA/PMN Number
K091216
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10379675
Device Catalogue Number10379675
Date Manufacturer Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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