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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER CORPORATION CLINITEK 50 URINE CHEMISTRY ANALYZER
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BAYER CORPORATION CLINITEK 50 URINE CHEMISTRY ANALYZER Back to Search Results
Catalog Number 10339859
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2022
Event Type  malfunction  
Manufacturer Narrative
The customer immediately unplugged the instrument when the smoke was seen.The clinitek 50 has reached it's end of support life and therefore has been discarded by the user and no further investigation is possible.The customer has been provided with a replacement instrument and is operational.The cause of this event is unknown.
 
Event Description
The customer reported visible smoke and a burnt smell while their clinitek 50 instrument was plugged into power.There were no visible flames.There is no report of injury due to this event.
 
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Brand Name
CLINITEK 50 URINE CHEMISTRY ANALYZER
Type of Device
CLINITEK 50
Manufacturer (Section D)
BAYER CORPORATION
1884 miles ave
p.o. box 70
elkhart IN 46514
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
511 benedict avenue
tarrytown NY 10591
Manufacturer Contact
felix akinrinola
2 edgewater drive
norwood, MA 02062
6107052212
MDR Report Key13549233
MDR Text Key285743890
Report Number3002637618-2022-00009
Device Sequence Number1
Product Code KQO
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K960546
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 02/17/2022
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 Number10339859
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/19/2022
Initial Date FDA Received02/17/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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