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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK STATUS+; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
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SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK STATUS+; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) Back to Search Results
Catalog Number 10379675
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2023
Event Type  malfunction  
Event Description
Customer states that they received a discrepant protein result compared to retesting on a lab instrument.There is no report of injury due to this event.
 
Manufacturer Narrative
Proper maintenance and technique were reviewed with the customer.The customer was not following the instrument manual instructions.The cause of this event is user error.
 
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Brand Name
CLINITEK STATUS+
Type of Device
METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
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
thomas myers
2 edgewater drive
norwood, MA 02062
MDR Report Key16736532
MDR Text Key313328408
Report Number3002637618-2023-00020
Device Sequence Number1
Product Code JIL
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 User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10379675
Device Lot Number207024
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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