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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK ATLAS
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SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK ATLAS Back to Search Results
Catalog Number 10309478
Device Problem False Negative Result (1225)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/29/2020
Event Type  malfunction  
Manufacturer Narrative
Siemens has dispatched service to troubleshoot the instrument.The customer's issue was resolved by replacing the optics lamp and cleaning the instrument.Subsequent calibration and qc is passing.Instrument is operational.
 
Event Description
The customer reported a false negative blood result on one patient sample on the clinitek atlas compared to retesting of the same sample on a manual dipstick and microscopic analysis.There is no report of injury due to this event.
 
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Brand Name
CLINITEK ATLAS
Type of Device
ATLAS
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
511 benedict avenue
tarrytown, ny
Manufacturer (Section G)
SPARTAN MEDICAL
22740 lunn road
cleveland, oh
Manufacturer Contact
felix akinrinola
511 benedict avenue
tarrytown, ny 
MDR Report Key10275531
MDR Text Key199072319
Report Number3002637618-2020-00032
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K932674
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10309478
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2020
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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