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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ATLAS
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SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ATLAS Back to Search Results
Catalog Number 10339544
Device Problem False Negative Result (1225)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/07/2018
Event Type  malfunction  
Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.Siemens service went onsite and has replaced the optics, decontaminated the readhead and replaced the reagent with a new lot.Customer service has ordered parts to troubleshoot the issue.A final report will be sent once the issue has been resolved.The cause of this event is unknown.
 
Event Description
The customer reported a false negative to trace blood result on a urine sample on the clinitek atlas when compared to microscopic sediment results.There was no report of injury due to this event.
 
Manufacturer Narrative
Siemens service went on site and replaced the pump, syringe and platen.Also, the read head was replaced due to a stripped screw.Calibration was run with no issues and the qc were in the expected ranges.The system was fully functional on departure and the customer is operational.
 
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Brand Name
CLINITEK ATLAS
Type of Device
CLINITEK ATLAS
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown NY 10591
MDR Report Key7966244
MDR Text Key123807156
Report Number3002637618-2018-00119
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
PMA/PMN Number
K932674
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 12/10/2018
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 Number10339544
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/21/2018
Initial Date FDA Received10/15/2018
Supplement Dates Manufacturer Received11/16/2018
Supplement Dates FDA Received12/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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